BONE HOOK

Additional Manufacturer Narrative

UPON RETURN OF THE DEVICE SUBJECT OF THE REPORTED EVENT, THE LOT NUMBER INDICATED THAT THE BONE HOOK WAS APPROXIMATELY 20 YEARS OLD. NORMAL WEAR AND TEAR WERE VISIBLE ON THE DEVICE. DURING EVALUATION OF THE BONE HOOK, THE REPORTED EVENT OF THE BROKEN PIECE WAS CONFIRMED. THE OBSERVED JAGGED EDGE WHERE THE PIECE OF THE BONE HOOKE BROKE OFF MAY BE ATTRIBUTED TO EXCESSIVE FORCE DURING USE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES WERE NOTED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A PIECE OF THE BONE HOOK "BROKE OFF" AND FELL INTO THE PATIENT. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE BONE HOOK SUBJECT OF THE REPORTED EVENT IS BEING SENT BACK FOR EVALUATION. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.