Arthrex® AR-13280-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867010598), received between Dec 13, 2021 and Jul 15, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 CANCELLOUS SCREW, AN AR-13380-54 CORTICAL SCREW, AN AR-13280-60 CANCELLOUS SCREW, AN AR-13380-50 CORTICAL SCREW, AN AR-13280-65 CANCELLOUS SCREW, AND AN AR-13380-46 CANCELLOUS 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 PROC

  Patient problems: Failure of Implant

  MAUDE report 19740495 ↗
• MalfunctionDec 13, 2021Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING THE REMOVAL OF THE PLATE AND THE SCREWS ONE YEAR AFTER A HIGH TIBIAL OSTEOTOMY SURGERY. THE SCREWS AND THE PLATE WERE DISCARDED AND THE REMAINING BROKEN PARTS WERE NOT REMOVED OUT OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 25-NOV-2021: IT WAS CONFIRMED THAT THE SCREWS WERE ALREADY BROKEN BEFORE THE SURGEON TRIED TO REMOVE THEM. THE SURGERY WAS NO REVISION, AS THE DEFECT OF THE DEVICES WAS NOT SEEN ON THE X-RAYS BEFORE SURGERY. THE CORRECTION OF THE HIGH TIBIAL OSTEOTOMY WAS STILL FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983575 ↗