ZIMMER BONE HOOK INSTRUMENT

Description of Event or Problem

IT IS REPORTED THAT THE BONE HOOK TIP BROKE OFF. IT WAS SUCTIONED UP AND COLLECTED FROM THE SUCTION MACHINE. NO PATIENT HARM.

Additional Manufacturer Narrative

INFORMATION WAS RECEIVED FROM A MEDWATCH FORM. EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED AND X-RAYS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, 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.