Arthrex® AR-8933V-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050235), received between Aug 8, 2023 and Aug 4, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionAug 4, 2025Failure to Advance; Failure to Advance

  ON 7/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT ONE AR-8933V-14 LOW PROFILE VA LOCKING SCREW, ONE AR-8933V-16 LOW PROFILE VA LOCKING SCREW, AND TWO AR-8933V-18 LOW PROFILE VA LOCKING SCREWS WERE UNSUCCESSFULLY THREADED THROUGH A LOCKING DISTAL FIBULAR PLATE, DESPITE APPROPRIATE DRILLING TECHNIQUES. AS A RESULT, ALL FOUR SCREWS WERE DISCARDED, AND THE PLATE HOLE REMAINED UNFILLED. THIS WAS DISCOVERED DURING AN ORIF ANKLE PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/21/2025: ON (B)(6) 2025, DURING AN ORIF ANKLE PROCEDURE, AN AR-9943BL-05 LOCKING DISTAL FIBULA PLATE WAS IMPLANTED AND REMAINS IN THE PATIENT. THERE WAS NO REPORT OF IMPLANT BREAKAGE DURING THE INCIDENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 10 MINUTES DUE TO DIFFICULTY ENGAGING THE SCREWS, WHICH REQUIRED REDRILLING AND REINSERTION. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO ACCOMMODATE THE EXTENDED OPERATIVE TIME. AN AR-8933GV DRILL GUIDE AND AN AR-8943-16 2.0 MM DRILL BIT WERE USED TO PREPARE THE BONE SOCKET FOR IMPLANT PLACEMENT. BONE QUALITY WAS ASSESSED AS ADEQUATE, AND NO PHOTOGRAPHS WERE TAKEN TO DOCUMENT THE ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698654 ↗
• 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, CALIBRA

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563022 ↗
• MalfunctionAug 8, 2023Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8933V-16 LOW PROFILE VA LOCKING SCREW WOULD NOT LOCK INTO THE PLATE. THE CASE WAS COMPLETED USING ANOTHER AR-8933V-16 LOW PROFILE VA LOCKING SCREW. THIS WAS DISCOVERED DURING AN MTP FUSION PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE SCREW WAS BEING USED WITH AN AR-8944CR-S LOW PROFILE MTP PLATE.

  Patient problems: Insufficient Information

  MAUDE report 17482527 ↗