NUGRIP SZ. 30L

Additional Manufacturer Narrative

B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT, H6: MEDICAL DEVICE PROBLEM CODE. SECTION H3, H6: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THAT THE IMPLANT WAS INTACT. THERE WERE VERY MINIMAL SIGNS OF WEAR FROM ATTEMPTED INSERTION. MINOR SCRATCHES ON STEM OF THE NUGRIP IMPLANT WERE PRESENT. THIS IS MOST LIKELY A RESULT OF ATTEMPTED INSERTION. NO OTHER DEFECTS WERE IDENTIFIED. THE IMPLANT HAS NO PART MARKINGS OR ENGRAVINGS ON THE DEVICE. BASED ON THESE OBSERVATIONS THE UNSATISFACTORY EXPERIENCE COULD BE CONFIRMED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW MADE BY THE QUALITY ENGINEERING TEAM REVEALED THAT THE SUPPLIER WAS NOTIFIED OF THE COMPLAINT. THE SUPPLIER PERFORMED AN INVESTIGATION AND CONCLUDED THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO THE 30L CONFIGURATION AND THE COATING THICKNESS CONFORMED TO THE SPECIFICATION REQUIREMENTS. NO SYSTEMIC MANUFACTURING ISSUES WERE IDENTIFIED. THE COMPLAINT DEVICE NOT FUNCTIONING PROPERLY IN THE FIELD IS LIKELY AN ISOLATED OCCURRENCE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. DIMENSIONAL EVALUATION OF THE RETURNED PRODUCT WAS CONDUCTED BY MEASURING THE LENGTH OF THE HEAD OF THE IMPLANT. PER DRAWING PRINT, THE ONLY UNIQUE VALUE BETWEEN SUBSTRATE SIZES IS THE MEASUREMENT OF THE IMPLANT HEAD. IT IS IMPORTANT TO NOTE THAT DIMENSIONAL ANALYSIS OF THIS PART IN NORMAL PRODUCTION OCCURS PRE-COATING. DIMENSIONAL ANALYSIS WAS ATTEMPTED TO MEASURE THE HEAD OF THE RETURNED PART TO CORRELATE IT TO THE SUBSTRATE MEASUREMENT PLUS THE COATING. ALL MEASURABLE CRITICAL FEATURES THAT COULD BE ANALYZED WERE WITHIN SPECIFICATION. HOWEVER, THE COATING THICKNESS VALUE PROVIDED BY THE VENDOR WAS FOUND TO BE OUT OF TOLERANCE. FURTHER EVALUATION WAS REQUESTED TO THE SUPPLIER. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT NO CLINICAL FACTORS HAVE BEEN CONCLUDED TO HAVE CONTRIBUTED TO THE REPORTED EVENT AND THE SUSPECTED SIZING DISCREPANCY AND/OR MISPACK, OR A USER VARIANCE CANNOT BE CONFIRMED BASED ON THE LIMITED INFORMATION PROVIDED. THE PATIENT IMPACT INCLUDED THE EXTENDED SURGICAL DELAY OF GREATER THAN 31 MINUTES DURING WHICH ADDITIONAL BROACHING, ATTEMPTED IMPLANTATION, AND COMPARISON OF TRIAL/FINAL COMPONENT WAS PERFORMED. PER CORRESPONDENCE, THE CURRENT PATIENT STATUS IS STABLE, AND THE PATIENT SUSTAINED NO INJURY DUE TO THE REPORTED EVENTS. A TRANSIENT POST-SURGICAL RECOVERY PHASE WOULD BE ANTICIPATED. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE SURGICAL TECHNIQUE FOR NUGRIP CMC IMPLANT REVEALED IN IMPLANTATION SECTION THAT THE APPROPRIATELY SIZED OF IMPLANT SHOULD BE SELECTED, AND INSERT THE DEVICE USING FINGER PRESSURE. ENSURE THE CORRECT AXIAL ROTATION OF THE IMPLANT IS MAINTAINED DURING INSERTION. CONFIRM THE DORSAL SURFACE OF THE IMPLANT STEM IS PARALLEL TO THE DORSAL SURFACE OF THE METACARPAL. LIGHTLY IMPACT THE IMPLANT WITH THE IMPACTOR PROVIDED AND REDUCE THE JOINT. BESIDES, EACH SURGEON MUST EVALUATE THE APPROPRIATENESS OF THE PRODUCTS AND TECHNIQUES ACCORDING TO THEIR OWN CLINICAL JUDGMENT FOR EACH OF THEIR PATIENTS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE SIZE SELECTED OR INSERTION TECHNIQUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED. H6: HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING A HAND JOINT REPLACEMENT SURGERY, A NUGRIP SZ. 30L IMPLANT WAS ATTEMPTED TO BE INSERTED, HOWEVER, IT WAS MUCH LARGER THAN THE TRIAL. SURGEON REMOVED AND ATTEMPTED TO BROACH METACARPAL FURTHER. THIS PROCESS CONTINUED FOR 30 MIN BUT CEASED SINCE SURGEON GOT CONCERNED OF CAUSING FRACTURE. THE IMPLANT WAS ATTEMPTED AGAIN BUT WAS UNSUCCESSFUL. SURGEON REQUESTED SIZE 20M OPENED; IMPLANT WAS OPENED AND COMPARED TO RELATING TRIAL SIZE. THE SIZE 20M AND CORRESPONDING TRAIL WERE IDENTICAL. A SECOND AVAILABLE 30L IMPLANT WAS OPENED AND WAS CORRECT AND IDENTICAL TO THE 30L TRIAL. IT WAS IMPLANTED IN PATIENT WITH NO FURTHER ISSUES. SURGERY WAS COMPLETED AFTER A SIGNIFICANT DELAY.