Arthrex® AR-13280-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867010550), received between Nov 7, 2017 and Jul 3, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-13380-42 CORTICAL SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PROCEDURE WAS A HIGH TIBIAL OSTEOTOMY. THE PATIENT DID NOT HAVE ANY SIGNIFICANT COMPLAINTS AND DID NOT RECALL AN EVENT OR INJURY TO HAVE OCCURRED. A COLLAPSE WAS NOTICED IN THE PATIENT'S OSTEOTOMY SITE. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT HAPPENED YET. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2023, AND REVISION SURGERY OCCURRED ON 6/9/2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: DURING THE REVISION SURGERY, AN AR-13200T-12.5 TIBIAL OPENING WEDGE OSTEOTOMY PLATE, TWO AR-13280-45 CANCELLOUS SCREW, AND THREE AR-13370-3 OSFERION OSTEOTOMY WEDGE WERE EXPLANTED ALONG WITH THE TWO BROKEN AR-13380-42 CORTICAL SCREWS. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 17246935 ↗
• InjuryAug 18, 2020Break; Device Slipped

  IT WAS REPORTED THAT AFTER AN INITIAL SUCCESSFUL SURGERY WHICH WAS PERFORMED ON (B)(6) 2019 A PATIENT COMPLAINT ABOUT PAIN NEARBY THE OSTEOTOMY. A CT AND X-RAY WAS PERFORMED AND CONFIRMED THAT THE SCREW HEADS WERE OUT OF THE PLATE AND THEREFORE FOUND TO BE BROKEN. A REVISION HIGH TIBIAL OSTEOTOMY WAS SUCCESSFULLY PERFORMED ON (B)(6) 2020 TO RETRIEVE THE SCREWS OUT OF THE PATIENT. UPDATE 27-JUL-2020: FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON TOOK OUT OF THE PLATE AND DID NOT IMPLANTED A NEW ONE AS HE THOUGHT THE (PARTIAL) CONSOLIDATION WAS ALREADY THERE.

  Patient problems: Pain

  MAUDE report 10421832 ↗
• 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 10421418 ↗
• InjuryJul 22, 2020Break

  IT WAS REPORTED THAT AFTER AN INITIAL SUCCESSFUL SURGERY WHICH WAS PERFORMED ON (B)(6)2019 A PATIENT COMPLAINT ABOUT PAIN NEARBY THE OSTEOTOMY. A CT AND Y-RAY WAS PERFORMED AND CONFIRMED THAT THE SCREW HEADS WERE OUT OF THE PLATE AND THEREFORE FOUND TO BE BROKEN. A REVISION HIGH TIBIAL OSTEOTOMY WAS SUCCESSFULLY PERFORMED ON (B)(6) 2020 TO RETRIEVE THE SCREWS OUT OF THE PATIENT.

  Patient problems: Pain

  MAUDE report 10307957 ↗
• InjuryNov 7, 2017Crack

  IT WAS REPORTED THAT THE DFO (DISTAL FEMORAL OSTEOTOMY) PROCEDURE AND SCREW DRILLING WENT WELL. GOOD ALIGNMENT OF THE PLATE. A CRACK WAS HEARD DURING THE FIXATION OF THE CORTICAL SCREWS. A FISSURE IN THE BONE WAS OBSERVED AT POST-OP RX. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE: AR-13110R-02 LOT 1478185 (CC127086 LINE 209696), AR-13280-35 LOT 1216262 (CC127086 LINE 210835), AR-13380-46 LOT 10129095 (CC127086 LINE 210838), AR-13280-45 LOT 10105613 (CC127086 LINE 210839), AR-13380-48 LOT 10073031 (CC127086 LINE 210841), AR-13380-52 LOT 10105330 (CC127086 LINE 210842), AR-13380-56 LOT 10123181 (CC127086 LINE 210844) AND AR-13280-70 LOT 10073626 (CC127086 LINE 210845).

  Patient problems: No Code Available

  MAUDE report 7005822 ↗