ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT PRESENTED 3 WEEKS OR 3 MONTHS POST-OP WITH A FRACTURED FEMUR AT THE LOCATION WHERE THE FEMORAL REFERENCE PINS WERE INSTALLED. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO CORRECT THE FRACTURE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THROUGH A MEDWATCH RECEIVED FROM THE FDA ALLEDGING OCCURANCES OF INACCURATE CUTS AND INCORRECT PLACEMENT OF IMPLANTS RESULTING IN PATIENT INJURIES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THERE WAS OVER RESECTION ON BOTH THE DISTAL FEMORAL AND PROXIMAL TIBIAL RESECTIONS, WITH A NET OVER RESECTION OF 4MM. THE CALIPER OF BONE MATCHED VALIDATED CUTS. PLANNED POLY WAS 10MM, RESULTING IN 13MM POLY WITH ADDITIONAL SOFT TISSUE RELEASES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), A DISTRIBUTORSHIP IN THE SOUTHEAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATIE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), A DISTRIBUTORSHIP IN THE SOUTH EAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATI

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AN INITIAL ROSA CEMENTLESS VANGUARD PS WAS PERFORMED WITH UNKNOWN INTRA-OPERATIVE PROBLEM. ON THE POST-OPERATIVE X-RAY, A COLLAPSE OF THE MEDIAL PLATEAU WAS SEEN AND A REVISION WAS PLANNED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROSA SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE ROSA HUMERAL CLAMP CREATED A HOLE THROUGH THE CORTICAL BONE, AND CAUSED A FRACTURE WHILE IMPLANTING THE STEM. FRACTURE OF THE HUMERUS NEEDED CERCLAGE WIRE AROUND FINAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NONE IS AVAILABLE AT THIS TIME.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE TIP OF THE REAMER WAS 6MM TOO POSTERIOR COMPARED TO PLAN. THE SURGEON HAD TO GRAFT THE HOLE AND REAMED AGAIN WITH CONVENTIONAL INSTRUMENTATION TO PREPARE THE CENTRAL HOLE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY WHICH HAD TO BE CANCELLED DURING THE PROCEDURE AS THE DISTAL RESECTION RESULTED IN SEVERE VALGUS.ALL LANDMARKS WERE TAKEN CORRECTLY AND NO DRIFTING OCCURRED DURING THE RESECTION. THE BONE HAD TO BE REBUILT WITH WEDGES. THERE WAS A 30 (THIRTY) MINUTE DELAY TO REBUILD THE BONE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE SURGEON QUESTIONED THE ALIGNMENT ON POST OP X-RAY GIVEN THE PLANNED AND VALIDATED CUTS MEASURED DO NOT CORRELATE. PLANNED FOR NEUTRAL TO SLIGHT VALGUS KNEE OVERALL, STARTED AT 18 DEG VALGUS. VALIDATED CUTS SUGGEST WE SHOULD HAVE ENDED UP AT NEUTRAL OR CLOSE TO HOWEVER ON POST OP X-RAYS HAVE ENDED AT 10 DEG VARUS. THE PATIENT HAS ALSO REPORTED SIGNS OF PAIN AND INSTABILITY. THE PATIENT IS BEING CONSIDERED FOR A REVISION. NO ADDITIONAL INFORMATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA ROBOTIC ASSISTED SURGERY THE POSTERIOR RESECTION WAS 4.5MM MORE THAN PLANNED ON BOTH SIDES, RESULTING IN AN UNEQUAL BALANCE BETWEEN EXTENSION AND FLEXION AND THE USE OF A THICKER POLY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TKA THE TIBIA WAS OVER RESECTED BY 3 MM. DUE TO THIS DISCREPANCY, A 16MM POLY INSERT WAS USED INSTEAD OF THE PLANNED 13MM INSERT. NO ADDITIONAL PATIENT IMPACT HAS BEEN REPORTED OTHER THAN THE DEVIATION FROM PLANNED IMPLANT SIZE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA PROCEDURE USING ROSA KNEE INSTRUMENTATION, THE PATIENT'S PROXIMAL TIBIA WAS OVER-RESECTED AND THE 4-IN-1 POSTERIOR FEMUR WAS UNDER RESECTED. THIS LEAD TO AN ANTERIOR FEMUR NOTCH, ALTHOUGH IT WAS WARNED AS POTENTIALLY AN ISSUE. SURGEON DECIDED TO PROCEED. ALL BONE CHIPS WERE CALIPERED. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOLLOWING A TKA DONE BY ROSA KNEE SURGICAL INSTRUMENTATION, FEMORAL NOTCHING WAS NOTICED IN THE POST OPERATIVE X-RAYS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE PLANNED DISTAL FEMUR CUT WAS 7/9.5MM. THE CUT BONE AND VALIDATED CUT WAS OVER RESECTED AT 10/12.5MM. THERE WAS NO ADDITIONAL IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION THE TIBIA WAS OVER-RESECTED BY 2MM MEDIALLY AND 3.5MM LATERALLY. DUE TO THIS DEVIATION FROM THE SURGICAL PLAN, A 16MM TIBIAL IMPLANT WAS NEEDED WHEN A 10MM IMPLANT WAS PLANNED. PATIENT HAD NO IMPACT AND WAS NOT AFFECTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY USING ROSA INSTRUMENTATION, THE TIBIA WAS OVER-RESECTED BY 3MM POSTERIOR-LATERAL. THIS WAS VALIDATED USING CALIPERS. TISSUE RELEASES AND BONE RECUTS HAD TO BE MADE TO BALANCE THE KNEE. A THICKER POLY HAD TO BE USED THAN WOULD HAVE BEEN THE CASE IF ROSA HAD CORRECTLY CUT THE REQUIRED AMOUNT OF BONE. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN INITIAL ROSA INSTRUMENTATION TKA SURGERY BOTH ROSA AND CALIPER VALIDATIONS CONFIRMED THAT THE TIBIA WAS OVER-RESECTED BY 4MM MEDIALLY AND 3MM LATERALLY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA PROCEDURE WHILE USING ROSA INSTRUMENTATION, THERE WAS AN OVER RESECTION FROM PLANNED TIBIAL CUT OF 6MM. A 16MM INLAY WAS USED AND THE KNEE WAS STABLE AND WELL BALANCED. AS OF THIS REPORT SUBMISSION THERE HAS BEEN NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA UTILIZING ROSA INSTRUMENTATION THE TIBIA WAS OVER RESECTED BOTH MEDIALLY AND LATERALLY 4MM. CALIPERS WERE USED TO VERIFY THAT EXCESSIVE BONE REMOVAL HAD OCCURRED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROSA TKA SURGERY THE 4-IN-1 CUT WAS NOT ACCURATE AND LED TO AN OVER-RESECTION. THE OVER-RESECTION WAS ENOUGH TO NOTCH THE FEMUR. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROBOTIC INSTRUMENTATION THE SURGEON PLANNED FOR TIBIA 0 DEGREE V/V CUT BUT ENDED UP IN 7 DEGREE VARUS (FROM POST-OP X-RAY). THE ROBOTIC SYSTEM SUGGESTED TIBIA BONE CUT OF 11.5MM ON LATERAL AND 9MM ON MEDIAL. THE VERIFIED CUT WAS 9MM MEDIAL AND 12MM LATERAL. VERIFICATION SHOWED 1 DEGREE OF VALGUS. FROM PRE-OP X-RAY TEMPLATING, SURGEON SHOULD HAVE CUT 12MM ON LATERAL AND 4MM ON MEDIAL TO GET THE KNEE STRAIGHT. NO MID SURGERY INTERVENTION OCCURRED. SURGEON EXECUTED THE SURGERY THAT WAS ORIGINALLY PLANNED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIAL RESECTIONS WERE AROUND 4-4.5 MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY (14MM) THAN PLANNED (10MM) WITH NO KNOWN REPORTED IMPACT TO THE PATIENT. PATIENT WAS PAIN FREE AND DISCHARGED 3 DAYS POST OP. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS INCIDENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA WERE 4MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY INSERT (16 MM) WITH NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY THE PATIENT EXPERIENCED APPROXIMATELY 1-2MM OF FEMORAL NOTCHING. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY THERE WAS A DISCREPANCY BETWEEN THE PLANNED AND VALIDATED RIGHT FEMORAL CUTS. THE PROCEDURE WAS DELAYED APPROXIMATELY 25 MINUTES. NO ADDITIONAL PATIENT IMPACT REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON FURTHER REVIEW, IT IS NOTED THE PATIENT EXPERIENCED A BLISTER. BLISTERS ARE A FLUID FILLED SAC LOCATED UNDER THE TOP LAYER OF THE SKIN. THESE RESULT DUE TO HEAT OR FRICTION AT THE SITE AND MOST OFTEN RESOLVE ON THEIR OWN. REVIEWING THE OFFICE NOTE PROVIDED, THE DOCTOR DOES NOT MENTION AN INTERVENTION AND STATES HE EXPECTS THE BLISTER TO RESOLVE ON ITS OWN. AS A BLISTER IS A MILD INJURY AND NO INTERVENTION IS NOTED, THIS WOULD NOT BE CONSIDERED A SERIOUS INJURY OR REPORTABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FEMORAL NOTCHING OCCURRED DURING A ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT INJURY WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE SURGEON WAS VALIDATING THE TIBIAL CUTS, THE SYSTEM WAS STATING THAT NOT ENOUGH WAS CUT PER THE PLAN AND THE ROD SHOWED BAD ALIGNMENT. THE SURGEON MADE ADDITIONAL CUTS TO BRING THE TIBIA INTO NEUTRAL ALIGNMENT WHEN HE SWITCHED TO CONVENTIONAL INSTRUMENTATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, METAL SHAVINGS WERE NOTICED WHEN DRILLING A TROCHAR PIN THROUGH ONE OF THE HOLES OF THE CUT GUIDE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION REPORTED.