HOOK/SCREW HOLDER
Received Feb 27, 2013 · Event occurred Jun 2, 2011
Report 3003787298-2013-10034 · MDR key 3015098
Device
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING EVALUATION REPORTS THE SAMPLE WAS RECEIVED IN 2 PIECES, A THREADED STEM AND AN THE OUTER SLEEVE. THE THREADED END OF THE THREADED STEM WAS BROKEN OFF. THE OUTER SLEEVE STEM SHOWS SIGNS OF USAGE. DUE TO THE BROKEN THREADED PORTION PREVENTED THE COMPLETION OF FUNCTIONAL EVALUATION AND MEASURING FOR THE T1 THREAD. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SPINE DEFORMITY PROCEDURE SURGEON USED THE HOOK OR SCREW HOLDER AND THE TIP BROKE OFF IN THE HEAD OF A SCREW. SURGEON WAS ABLE TO REMOVE THE PIECE. SURGEON THEN USED THE ROD INDUCTION PLIERS AND THEY CRACKED. SURGEON SELECTED ANOTHER AND COMPLETED THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.