Arthrex® AR-8943-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867052260), received between Sep 7, 2021 and May 5, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A REPAIR OF A FRACTURE OF THE FOOT¿ANKLE COMPLEX THE DRILL BIT BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083183 ↗
• MalfunctionOct 8, 2024Break; Break

  NO REVISION IS REQUIRED. THERE WAS NO PROCEDURE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20397518 ↗
• InjuryJul 3, 2023Break; Break

  ON 6/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8943-16 DRILL BIT BROKE DURING FIBULAR DRILLING, AND THE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 17247211 ↗
• MalfunctionMay 4, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8943-16 DRILL BIT BROKE DURING SURGERY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT, DEVICE BREAKS DURING USE. MATERIAL BROKE DURING THE PROCESS. THE PATIENT HAD NO MAJOR PROBLEMS AND THE DOCTOR WAS ABLE TO FINISH THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870647 ↗
• MalfunctionJan 23, 2023Break; Entrapment of Device

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8943-16 DRILL BIT BROKE DURING A FIBULA ORIF PROCEDURE. THE DOCTOR WAS DRILLING THE FAR CORTEX OF THE FIBULA WITH THE 2MM DRILL WHEN THE DRILL BROKE AND BECAME LODGED IN THE FIBULAR INTER MEDULLARY CANAL. THE DRILL BIT PIECE WAS UNABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16223195 ↗
• MalfunctionSep 7, 2021Break

  ON 8/19/2021 IT WAS REPORTED BY ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8943-16 BROKE WHEN MAKING A HOLE WHILE USING THE FIBULA PLATE. THIS OCCURRED DURING USE ON (B)(6) 2021. THE BROKEN PIECE WAS RECOVERED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING ANOTHER DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435136 ↗