OXFORD MEDIUM SIZE 4/5MM TRIAL BEARING

Description of Event or Problem

IT WAS REPORTED THAT DURING THE TRIAL REDUCTION PORTION OF A SURGERY ON AN UNKNOWN DATE, THE TRIAL BEARING SNAPPED AWAY FROM THE METAL ROD AND COULDN'T BE REMOVED. ALL IMPLANTS HAD TO BE REMOVED TO FREE THE BEARING. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT.

Additional Manufacturer Narrative

THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. NO ITEM OR LOT NUMBERS WERE REPORTED. DATE OF EVENT - UNKNOWN. MANUFACTURE DATE - UNKNOWN. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

Additional Manufacturer Narrative

BEARING WAS RETURNED AND EVALUATED. THE PRODUCT LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT AVAILABLE. DIMENSIONAL CHECK TO THE DRAWING FOUND NO DEVIATIONS THAT WOULD HAVE RESULTED IN THE REPORTED ISSUE. VISUAL EXAMINATION FOUND MARKS AND INDENTS INDICATING THE ITEM HAD BEEN USED A NUMBER OF TIMES. INSPECTION OF THE RETURNED ITEM CONCLUDED THE ITEM PROBABLY FRACTURED DUE TO WEAR AND TEAR.