Arthrex® AR-13380-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867011601), received between Jul 19, 2017 and Jul 15, 2024 — classified as 3 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 3 most recent of 3 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 REPORTED THAT A REVISION

  Patient problems: Failure of Implant

  MAUDE report 19740491 ↗
• InjuryNov 7, 2017Crack

  IT WAS REPORTED THAT THE DFO (DISTAL FEMORAL OSTEOTOMY) PROCEDURE WENT WELL , GOOD ALIGNEMENT OF THE PLATE. ALL SCREWS WERE DRILLED WITH AR-13319. A CRACK WAS HEARD DURING THE FIXATION OF THE CORTICAL SCREWS. A FISSURE IS VISIBLE IN THE POST OP X-RAY. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE: AR-13110R-01 LOT 1142477 (CC127085 LINE 209692), AR-13280-70 LOT 10076262 (CC127085 LINE 210847), AR-13380-42 LOT 10081230 (CC127085 LINE 210849), AR-13380-46 LOT 10084866 (CC127085 LINE 210851), AR-13380-56 LOT 1142998 (CC127085 LINE 210852) AND AR-13380-50 LOT 10081367 (CC127085 LINE 210854).

  Patient problems: No Code Available

  MAUDE report 7005816 ↗
• InjuryJul 19, 2017Device Damaged by Another Device

  IT WAS REPORTED THAT THE FIRST SCREW (LINE 199106) 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 (LINE 199105) WAS USED. WHEN IMPLANTING THE FIRST CORTICAL SCREW, AR-13380-54 (LINE 199106) 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 (LINE 200047), AR-13380-46 (LINE 200051) AND AR-13380-36 (LINE 200053). 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 6725291 ↗