Arthrex® AR-9943BL-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867255609), received between Aug 17, 2023 and Aug 13, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• MalfunctionAug 13, 2025Positioning Failure; Positioning Failure

  ON 07/28/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-8935CL-14 KREULOCK COMPRESSION SCREW (3.5 MM X 14 MM) FAILED TO ENGAGE WITH THE LOCKING MECHANISM OF AN AR-9943BL-04 LOCKING DISTAL FIBULA PLATE DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. DESPITE PROPER DRILLING USING THE DESIGNATED DRILL TOWER, BOTH SCREWS SPUN FREELY WITHIN THE HOLE AND DID NOT LOCK INTO THE PLATE. A 4.0 MM CORTICAL SCREW WAS ULTIMATELY USED TO FILL THE HOLE; HOWEVER, LOCKING WAS NOT ACHIEVED, AND THEY SUSPECT THAT THE ISSUE IS WITH THE LOCKING THREADS ON THE PLATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/01/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793773 ↗
• InjuryAug 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 FOR AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT TRIMALLEOLAR ANKLE FRACTURE WITH FIXATION OF THE DISTAL FIBULA FRACTURE, POSTERIOR MALLEOLUS FRACTURE, AND SYNDESMOTIC FIXATION. DURING THE (B)(6) 2018 SURGERY, THE FOLLOWING PRODUCTS WERE USED AND/OR IMPLANTED: AR-8740-52PTS QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 52MM, LOT/SERIAL (B)(6). AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI, LOT/SERIAL (B)(6). AR-8933-20 LO-PRO SCRW,TI,3.0MMX 20MMCORT, LOT/SERIAL (B)(6). AR-8933V-12 3.0 X 12MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-14 3.0 X 14MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-16 3.0 X 16MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-18 3.0 X 18MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8933V-20 3.0 X 20MM VAL SCREW, TI, LOT/SERIAL (B)(6). AR-8935-12 LO-PRO SCRW,TI,3.5MMX 12MM, LOT/SERIAL (B)(6). AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6). AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6). AR-8935-26 LO-PRO SCRW,TI,3.5MMX 26MM, LOT/SERIAL (B)(6). AR-8943-01 GUIDE WIRE, TROCAR TIP, 1.35 MM, LOT/SERIAL (B)(6). AR-8943-02 DRILL BIT, CANNULATED, 2.6MM, LOT/SERIAL (B)(6). AR-8943-16 2.0MM DRILL BIT, CALIBR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563229 ↗