Arthrex® AR-13280-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867010536), received between Nov 7, 2017 and Jul 3, 2023 — 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 18, 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 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW BROKE POST-OPERATIVE. THIS WAS DISCOVERED DURING A POST-OPERATION FOLLOW-UP X-RAY ON (B)(6) 2023. THE PATIENT HAS COMPLAINED OF A SENSATION OF INSTABILITY BUT DOES NOT REPORT A SPECIFIC EVENT OR TIME FRAME IN WHICH THE INSTABILITY STARTED. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT OCCURRED YET. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2022, AND REVISION SURGERY OCCURRED ON (B)(6)2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023: DURING THE REVISION SURGERY, AN ABS-3016 SYNTHETIC BONE FILLER, AN AR-13200ST-17.5 TIBIAL A/P SLOPED OSTEOTOMY PLATE, THREE AR-13370-4 OSFERION OSTEOTOMY WEDGE, AN AR-13380-40 CORTICAL SCREW, AND AN AR-13380-46 CORTICAL SCREW WERE EXPLANTED ALONG WITH THE BROKEN AR-13280-35 AND AR-13280-50 CANCELLOUS SCREW. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17247755 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 7005818 ↗