Arthrex® AR-8935CL-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867323063), received between May 9, 2024 and Aug 13, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 5 most recent of 5 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 22793779 ↗
• MalfunctionAug 13, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 08/06/2025: DURING A SURGICAL PROCEDURE, THEY ENCOUNTERED AN ISSUE WITH THE AR-9943BL-04 LOCKING DISTAL FIBULA PLATE (LOT #15080923). WHILE ATTEMPTING TO INSERT SCREWS, NO RESISTANCE OR TACTILE FEEDBACK WAS NOTED. HOWEVER, TWO AR-8935CL-14 KREULOCK COMPRESSION SCREWS (LOT #15392704 AND #15421090) FAILED TO LOCK INTO ONE OF THE PLATE HOLES. ALL OTHER HOLES ON THE PLATE FUNCTIONED NORMALLY WITH SIMILAR SCREWS. THE FAILED SCREWS WERE REMOVED FROM THE PATIENT AND SHOWED SIGNS OF DAMAGE AT THE HEAD. TO COMPLETE THE CASE, A 4.0 MM CORTICAL SCREW, AR-8940-14 (LOT #15328861) WAS USED TO FILL THE HOLE, ALTHOUGH LOCKING WAS NOT ACHIEVED. THERE WAS A MINOR DELAY IN THE PROCEDURE WHILE A SECOND SCREW WAS ATTEMPTED, AND THE CORTICAL SCREW WAS INSERTED. NO ADDITIONAL ANESTHESIA WAS REQUIRED. BONE QUALITY WAS ASSESSED AS FAIR, AND NO INSTRUMENTS WERE USED TO TAP OR PREPARE THE BONE SOCKET. NO PIECES OF THE IMPLANT OR INSTRUMENTS BROKE DURING THE PROCEDURE, AND NO FRAGMENTS WERE LEFT BEHIND. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793774 ↗
• MalfunctionJul 17, 2024Positioning Failure; Positioning Failure

  ON 06/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8935CL-12 KREULOCK SCREW, AND AN AR-8935CL-14 KREULOCK SCREW WOULD NOT LOCK INTO THE PLATE. THIS OCCURRED DURING A SYNDESMOSIS REPAIR ON (B)(6) 2024 THAT WAS COMPLETED USING AN AR-8935CL-12 KREULOCK SCREW THAT WORKED ACCORDINGLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763254 ↗
• MalfunctionMay 9, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935CL-14KREULOCK SCREW WENT RIGHT THROUGH AN AR-9943T-05 LOCKING THIRD TUBULAR PLATE DURING INSERTION. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022. SURGEON BACKED THE SCREW OUT A FEW TURNS AND LEFT IT IMPLANTED IN THE PATIENT. IT IS NOW ACTING AS A NON-LOCKING SCREW.

  Patient problems: Insufficient Information

  MAUDE report 19277070 ↗
• MalfunctionMay 9, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935CL-14 KREULOCK SCREW WOULD NOT FULLY SEAT, AS IF IT DID NOT FIT THE PLATE. THE SURGEON REMOVED THE SCREW MULTIPLE TIMES AND ATTEMPTED TO RE-INSERT THE PLATE WITH THE SAME OUTCOME. THE CASE WAS COMPLETED USING A DIFFERENT SCREW. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/22/2024: THE CASE WAS COMPLETED USING ANOTHER AR-8935CL-14 KREULOCK SCREW WITH THE SAME PLATE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT UNNECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276981 ↗