13 X 90MM LAG FASTENER

Additional Manufacturer Narrative

AN INVESTIGATION WAS CONDUCTED WHICH INCLUDED REVIEW OF APPLICABLE PRODUCTION RECORDS AND DIMENSIONAL EVALUATION OF RETURNED COMPONENTS. THE REPORTED DEVICE MALFUNCTION WAS CONFIRMED. NO MANUFACTURING NONCONFORMANCES OR PRODUCT SPECIFICATION DEVIATIONS WERE IDENTIFIED AS IT RELATES TO THE REPORTED ISSUE. THE CAUSE OF THE REPORTED BREAKAGE COULD NOT BE CONCLUSIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. NO ADDITIONAL ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THE REPORTED DEVICE MALFUNCTION WERE IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT FEMORAL NECK FRACTURE REPAIR SURGERY ON (B)(6) 2026. FOLLOW-UP EVALUATION PERFORMED BETWEEN THE INITIAL SURGERY AND (B)(6) 2026 REVEALED THAT THE FRACTURE HAD NOT HEALED. REVISION SURGERY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2026. DURING THE REVISION PROCEDURE, IT WAS DETERMINED THAT ONE 13 X 90 MM LAG FASTENER (PART 324-13090, LOT HFI042) AND TWO 6.0 X 95 MM BONE SCREW FASTENERS ST (PART 360-1095, LOT HFV009) HAD BROKEN. THE DATE THE DEVICES BROKE IS UNKNOWN. THE 13 X 90 MM LAG FASTENER WAS COMPLETELY REMOVED AND RECOVERED. THE TWO 6.0 X 95 MM BONE SCREW FASTENERS ST WERE PARTIALLY REMOVED, WITH THE DISTAL TIP FRAGMENTS REMAINING IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THE REPORTED DEVICE ISSUE WERE REPORTED.