Arthrex® AR-13280-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867010581), received between Aug 18, 2020 and Aug 20, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Break; Break

  ON 7/22/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-13280-60 CANCELLOUS SCREW BROKE IN THE PATIENT. THIS WAS DISCOVERED DURING AN OSTEOTOMY PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 8/1/2024: THE BROKEN SCREW FRAGMENTS WERE NOT REMOVED. THE CASE WAS COMPLETED USING A NEW PLATE AND SCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003679 ↗
• 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 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 P

  Patient problems: Failure of Implant

  MAUDE report 19740478 ↗
• 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: Foreign Body In Patient

  MAUDE report 12983612 ↗
• InjuryAug 18, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT AFTER AN INITIAL HTO SURGERY ON (B)(6) 2019, IT WAS FOUND THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. THE SCREWS COULD NOT BE REMOVED DURING THE REVISION SURGERY. IT'S UNCLEAR IF THE SCREWS BROKE IN SITU OR DURING THE REVISION SURGERY. NO MORE INFORMATION AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. FURTHER QUESTIONS WILL BE ASKED UPDATE 12-AUG-2020: IT WAS REPORTED BY THE CUSTOMER THAT SOME PROXIMAL SCREWS WERE BROKEN. WHEN REMOVING THE PLATE AND SCREWS THEY ALL BROKE AROUND 1CM FROM SCREWHEAD. THE PLATE AND SCREWS WERE (PARTIALLY) TAKEN OUT. THE SURGEON DECIDED THAT HE DID NOT WANT TO PLACE ANOTHER PLATE DUE TO PARTIAL CONSOLIDATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10421987 ↗
• InjuryAug 18, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT THE PROXIMAL SCREWS BROKE POST OP AND REMAINS IN THE PATIENTS BODY. NO MORE INFORMATION ARE AVAILABLE. NO X-RAYS ARE AVAILABLE. DEVICES ARE ALREADY DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. UPDATE 17-AUG-2020: DURING A REMOVAL SURGERY THE HEAD OF THE SCREWS BROKE OFF AT THE PROXIMAL END. THE DISTAL PART OF THE SCREWS COULD NOT BE REMOVED AND WILL BE LEFT INSIDE OF THE PATIENT. THE PLATE AND THE HEAD OF THE SCREWS WERE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10421502 ↗