Arthrex® AR-8943-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867052239), received between Jun 20, 2024 and May 7, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 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.

• MalfunctionMay 7, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY WHILE PERFORMING THE CORTICAL DRILLING, THE DRILL COLLAPSED WITHOUT CAUSING ANY CONSEQUENCES. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 28-APR-2026 FURTHER INFORMATION WAS PROVIDED THAT THE ERROR OCCURRED DURING AN ANKLE FRACTURE SURGERY ON THE (B)(6) 2026. 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 25116258 ↗
• MalfunctionJun 20, 2024Material Fragmentation; Material Fragmentation

  PER LOAN / CONSIGNMENT INSPECTIONS OPERATOR: DURING INSPECTION OF SET 10325519 IT WAS NOTED THAT THE PAINT GROOVE CHIPPED. THE DEVICE WAS SENT IN WITHOUT ANY CUSTOMER ALLEGATION. THERE WAS NO HARM OR ADVERSE EVENT REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579039 ↗