IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,5X480MM

Additional Manufacturer Narrative

PLEASE NOTE THE CORRECTION TO D4 LOT #. THE REPORTED EVENT COULD BE CONFIRMED SINCE THE DEVICE WAS RETURNED AND MATCHES THE ALLEGED FAILURE. DEVICE INSPECTION REVEALED THE FOLLOWING: FROM THE VISUAL INSPECTION OF THE RETURNED IM REAMER WHERE THE SPIRAL WAS ALSO FOUND TO BE BROKEN FROM THE POINT WHERE IT IS WELDED WITH THE ADAPTER. AROUND THAT REGION, A BURN MARK CAN BE SEEN WHICH IS A SIGN OF EXCESSIVE RESTRICTED ROTATION UP TO A POINT OF HEAT GENERATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO USER RELATED AS BREAKAGE WAS CAUSED DUE TO APPLICATION OF HIGH TORSIONAL LOAD. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT AN IM FLEXIBLE REAMER WAS BROKEN DURING SURGERY WHICH RESULTED IN A 20 MINUTE SURGICAL DELAY. THERE WAS NO DEBRIS.

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT AN IM FLEXIBLE REAMER WAS BROKEN DURING SURGERY WHICH RESULTED IN A 20 MINUTE SURGICAL DELAY. THERE WAS NO DEBRIS.