Arthrex® AR-8943-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867052222), received between May 10, 2021 and May 22, 2025 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Break; Break

  FURTHER INFORMATION WAS RECEIVED THAT A SMALL SURGERY MEANS AN ANKLE SURGERY IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074234 ↗
• InjurySep 27, 2023Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device

  ON 30TH AUGUST 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL CONCERNING 2 PIECES OF AR-8840C-45, LOW PROFILE SCREW¿, SS, 4.0 X 45 MM, CANNULATED, SHORT THREAD. FOR 1 OF THE AR-8840C-45, ITS SCREW HEAD WAS STRIPPED. BOTH WERE EVENTUALLY REMOVED FROM THE PATIENT DUE TO REDUCTION LOSS. THIS OCCURRED DURING A LEFT OPEN REDUCTION INTERNAL FIXATION ANKLE FRACTURE PROCEDURE ON (B)(6) 2023. AS PART OF A LEFT ANKLE ORIF (ALSO INCLUDING PLATE AND SYNDESMOSIS TIGHTROPES), SURGEON ATTEMPTED TO INSERT 2X 4.0MMX 45MM SHORT-THREAD CANNULATED SCREWS AR-8840C-45 INTO THE MEDIAL SIDE OF THE ANKLE. PER TECHNIQUE, THE SURGEON FIRST USED 1.35MM GUIDE WIRE AR-8943-01, GUIDE WIRE, TROCAR TIP, 1.35 MM X 130 MM, THEN OVERDRILLED WITH A AR-8943-02, DRILL BIT, CANNULATED, 2.6 MM. WHEN INSERTING THE SCREW USING THE AR-8943-12, DRIVE SHAFT, CANNULATED, QC, T15 HEXALOBE PER SURGICAL TECHNIQUE, THE SURGEON STATED THAT SHE WAS UNABLE TO ADVANCE THE SCREW PROPERLY AS THE DRIVER SHAFT WAS NOT ENGAGING PROPERLY WITH THE SCREW. FOR THE SECOND IDENTICAL SCREW, THE SURGEON SWITCHED TO THE AR-8943-09, SCREWDRIVER, T15 HEXALOBE, CANNULATED AND THE SURGEON STATED THAT THIS SCREW ADVANCED MORE SUCCESSFULLY. UPON IMAGING,

  Patient problems: Insufficient Information

  MAUDE report 17824949 ↗
• MalfunctionMay 10, 2021Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PAINT WAS FLAKING OFF OF THE FOLLOWING DEVICES. THE FLAKES WERE REMOVED FROM THE PATIENT. NO PATIENT HARM. AR-8943-09, LOT: 1391715, AR-8943-12, LOT: 6791217, AR-8943-14, LOT: 5262019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11799554 ↗