Arthrex® AR-8933V-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867050259), received between Feb 15, 2018 and Aug 17, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 DRI

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563048 ↗
• InjuryFeb 15, 2018Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT PAIN IN THE SURGICAL AREA. THE SURGEON FOUND OUT THAT 2 SCREWS BROKE POST-OP. ON THE REVISION SURGERY THE PLATE AND SCREWS WERE COMPLETELY REMOVED AND A NEW PLATE WAS IMPLANTED. ACCORDING TO THE SURGEON THE PATIENT WAS NON-COMPLIANT TO THE POST-OP GUIDELINES.

  Patient problems: Pain

  MAUDE report 7273909 ↗