M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM

Additional Manufacturer Narrative

THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS TAPPING THE S2AI SCREW, HE COULD ONLY GET THE SCREW TO SEAT 80%. WHEN HE TRIED TO REMOVE THE SCREW WITH THE SCREWDRIVER, THE SCREWDRIVER BROKE. THE SURGEON TRIED ANOTHER SCREWDRIVER TO REMOVE THE SCREW WHICH ALSO BROKE. THE SURGEON TOOK A SAW AND CUT THE HEAD OFF THE SCREW AND LEFT THE SHAFT IN THE PATIENT. ADDITIONALLY, ON THE SI SCREW, THE SURGEON TRIED TO ADVANCE THE SCREW, AND THE IMPLANT FAILED 1/3 OF THE WAY DOWN. THE IMPLANT SHEARD OFF INSIDE THE DRIVER. THERE WAS A 45-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 08 OCTOBER 2024. LOT: 2124492: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2022. EXPIRATION DATE: 2027-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: PEDICLE SCREW MUST S2AI HA SCREW Ø8X80 STD FULL THREAD (K234048) LOT: 2328888: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2024. EXPIRATION DATE: 2029-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

Additional Manufacturer Narrative

CORRECTION: H8 INITIAL USE.