ACCOLADE OFFSET RASP HANDLE

Additional Manufacturer Narrative

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Description of Event or Problem

THE SURGEON WAS USING THE EXETER BROACH HANDLE IN A TOTAL HIP REPLACEMENT WHEN IT BROKE. THE WHEEL SNAPPED OFF.

Additional Manufacturer Narrative

AN EVENT REGARDING CRACKING/FRACTURE INVOLVING AN ACCOLADE HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: EXAMINATION WITH MATERIAL ANALYSIS ENGINEER CONFIRMED THE IMPACTION PAD BROKE FROM THE RASP HANDLE BODY AT THE WELD LOCATION. THE FRACTURE SURFACE WAS CONFIRMED TO BE CONSISTENT WITH SIMILAR EVENTS REPORTED FOR THIS PRODUCT AND UNDER THE SCOPE OF NCR M08-1901, THEREFORE FURTHER EVALUATION IS NOT REQUIRED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT WAS CONFIRMED. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NCR (B)(4) RESULTED IN REGULATORY ACTION RA2009-050 (APPROVED NOV. 1, 2010) WHICH RECALLED THE DEVICE FOR THE POTENTIAL FRACTURING/BREAKAGE OF THE STRAIGHT RASP HANDLE. ALL LOTS WERE RECALLED. THE DEVICE REPORTED IN THIS EVENT WAS MANUFACTURED BEFORE THIS RECALL.

Description of Event or Problem

THE SURGEON WAS USING THE EXETER BROACH HANDLE IN A TOTAL HIP REPLACEMENT WHEN IT BROKE. THE WHEEL SNAPPED OFF.