Arthrex® AR-7268Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867369894), received between Jul 6, 2023 and Aug 7, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177418 ↗
• MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE TORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353905 ↗
• InjuryFeb 2, 2024Break; Break

  ON 01/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2023 WHERE AN AR-2652CL CLAVICLE FRACTURE PLATE, AN AR-8835-14 LOW PROFILE SCREW, (2) AR-8835-16 LOW PROFILE SCREWS, AN AR-8835CL-12 KREULOCK COMPRESSION SCREW, (2) AR-8835CL-14 KREULOCK COMPRESSION SCREWS, AN AR-8835-10 LOW PROFILE SCREW, AN AR-7268 FIBERTAPE® CERCLAGE WITH TIGERLINK, AND AN AR-7268T TIGERTAPE® CERCLAGE WITH FIBERLINK WERE IMPLANTED. FIVE WEEKS POST-OP, THE PATIENT REPORTED HEARING OR FEELING A POP. AN X-RAY WAS TAKEN THAT CONFIRMED THAT THE AR-2652CL PLATE HAD BROKEN. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTED DEVICES WERE REMOVED. THE REVISION WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 18634412 ↗
• InjuryJul 6, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-7268 CERCLAGE BROKE AFTER IT WAS IMPLANTED INTO A PATIENT. INITIAL SURGERY OCCURRED ON (B)(6) 2023, REVISION SURGERY OCCURRED ON (B)(6) 2023. REVISION SURGERY WAS TO REPLACE SHORT STEM REVERSE SHOULDER WITH A LONG STEM SHOULDER PROSTHESIS IN A PATIENT WITH A FRACTURE OF THE PROXIMAL HUMERUS. CERCLAGE WAS USED AS ONE OF THREE ITEMS TO REPAIR. PATIENT SUFFERED ANOTHER ACCIDENT AFTER THE SURGERY PROMPTING THE REVISION TO REPAIR A SECOND TIME. DURING THE SURGERY THE SURGEON NOTICED THE CERCLAGE WAS BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 17267604 ↗