BIGLIANI/FLATOW PEGGED GLENOID DRILL GUIDE

Additional Manufacturer Narrative

EVALUATION SUMMARY: THE RETURNED DEVICE WAS INSPECTED PER PRINT AND ALL FEATURES WERE FOUND CONFORMING WITH THE EXCEPTION OF THE FRACTURE. THE GUIDE HOLES SHOW SIGNS OF SIGNIFICANT WEAR FROM ITS POTENTIAL FIELD LIFE OF APPROXIMATELY 5.5 YEARS AND HAS BEEN USED AN UNKNOWN NUMBER OF TIMES DURING THAT TIMEFRAME. IT IS LIKELY THAT DAMAGE TO THE GUIDE WAS ACCRUED DURING PREVIOUS USE AND THIS DAMAGE CAUSED INTERFERENCE BETWEEN THE GUIDE AND DRILL BIT. THIS INTERFERENCE GENERATED A BURR THAT BECAME TRAPPED IN THE GUIDE CAUSING THE BIT TO BIND UP AND APPLYING ROTATIONAL FORCES ON THE GUIDE, IT WAS NOT DESIGNED FOR. THESE ROTATIONAL FORCES CAUSED THE HANDLE TO FRACTURE. THIS FRACTURE CAN MOST LIKELY BE ATTRIBUTED TO NORMAL WEAR AND TEAR. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem

IT IS REPORTED THAT THE DRILL BIT BOUND UP WITHIN THE PEGGED DRILL GUIDE CAUSING THE GUIDE'S HANDLE TO BE TORQUED AND FRACTURED OFF. EVERYTHING WAS RETRIEVED FROM THE PATIENT.