SHARP HOOK

Additional Manufacturer Narrative

THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

Description of Event or Problem

IT WAS REPORTED: THE TIP OF THE SHARP HOOK BROKE OFF DURING A PROCEDURE. PATIENT WAS PREVIOUSLY IMPLANTED (APPROXIMATELY 40 YEARS AGO) WITH AN UNIDENTIFIABLE PLATE WITH UNIDENTIFIABLE SCREWS THAT LOOK LIKE PHILLIPS HEAD SCREWS. PLATE AND ALL SCREWS WERE INTACT. SURGEON WAS USING THE SHARP HOOK TO CLEAN OUT THE HEADS OF THE SCREWS AND THE TIP OF THE HOOK BROKE OFF. TIP WAS NOT RETRIEVED. X-RAY WAS USED AND THE TIP WAS NOT FOUND IN THE PATIENT. PATIENT WAS THEN FLUSHED TO REMOVE ANY DEBRIS. HARDWARE WAS BEING REMOVED IN ORDER TO RE-PLATE THE PATIENT FOR A FRACTURE DISTAL TO THE PREVIOUS PLATE. THE PROCEDURE WAS COMPLETED WITH AN APPROXIMATE 30 MINUTE DELAY. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).