Arthrex® AR-13380-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867011625), received between Jul 19, 2017 and Jul 15, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2024Break; Break

  ON 04/24/2024: IT WAS REPORTED, BY A PATIENT VIA PHONE. THAT AFTER, UNDERGOING A DISTAL FEMUR OSTEOTOMY ON (B)(6) 2023, ONE OF THE SIX IMPLANTED SCREWS BROKE. THIS WAS DISCOVERED 3 1/2 MONTHS POST-OP IN AN X-RAY. ON (B)(6) 2023, WHEN THIS PROCEDURE TOOK PLACE, AN AR-13280-60, CANCELLEOUS SCREW; AN AR-13380-54, CORTICAL SCREW; AN AR-13280-60, CANCELLEOUS SCREW; AN AR-13380-50, CORTICAL SCREW; AN AR-13280-65, CANCELLEOUS SCREW AND AN AR-13380-46, CANCELLEOUS SCREW WERE IMPLANTED. IT HAS NOT BEEN CONFIRMED, WHICH SCREW BROKE. A POST-OP X-RAY WAS TAKEN 2 MONTHS, POST-OP WHERE EVERYTHING LOOKED GOOD. HOWEVER, THE X-RAY TAKEN 3 1/2 MONTHS POST, SHOWED A BROKEN SCREW THAT HAD PARTIALLY MADE ITS WAY. THE INTEGRITY OF THE HEALING BONE WILL DETERMINE, WHEN A REVISION WILL BE TAKING PLACE. ADDITIONAL INFORMATION, WAS PROVIDED BY THE PATIENT. WHERE HE STATED, THAT A TEST HAD BEEN RUN TO CONFIRM, THERE WERE NO DEFICIENCIES WITH HIS HEALTH, THAT WOULD CAUSE THIS FAILURE. THE PATIENT WILL BE UNDERGOING A REVISION SURGERY WITH A TRAUMA SURGEON. THERE PATIENT STATED, HIS FEMUR IS NOW SHORT ON BOTH SIDES, DUE TO THE BREAKAGE. ADDITIONAL INFORMATION, WAS PROVIDED ON 06/27/2024. WHERE THE PATIENT REPO

  Patient problems: Failure of Implant

  MAUDE report 19740473 ↗
• InjuryJul 19, 2017Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE FIRST SCREW ((B)(4)) CAUSED A VERTICAL FRACTURE OF THE FEMUR. A TOTAL OF 7 SCREWS WERE USED; THE FRACTURE GOT LONGER WITH EACH SCREW. THE CASE WAS FINISHED AND CERCLAGE WIRE WAS USED TO HOLD THE FEMUR TOGETHER. FEMORAL OSTEOTOMY. NO ADDITIONAL HOSPITALIZATION WAS NEEDED. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT DURING A FEMORAL OSTEOTOMY CASE THE CONTOURLOCK FEMORAL OSTEO SMALL RIGHT PLATE, AR-13110R-01 ((B)(4)) WAS USED. WHEN IMPLANTING THE FIRST CORTICAL SCREW, AR-13380-54 ((B)(4)) IN THE MOST DISTAL OF THE PROXIMAL HOLES THE FEMUR BEGAN TO FRACTURE. THE FRACTURE CONTINUED AS THE SCREWS WERE IMPLANTED DISTAL TO PROXIMAL. THE SCREWS WERE IMPLANTED AS FOLLOWS: AR-13380-50 ((B)(4)), AR-13380-46 ((B)(4)) AND AR-13380-36 ((B)(4)). THE CASE WAS COMPLETED USING ANOTHER MANUFACTURE'S 18 GAUGE WIRE (QTY. 2) TO SECURE THE FRACTURE IN CERCLAGE TECHNIQUE. AT THIS TIME THE PATIENT HAS NOT HAD A POST OP RECHECK. PATIENT IS MALE, (B)(6). NO ADDITIONAL HOSPITALIZATION WAS NEEDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6725285 ↗