Arthrex® AR-8933V-12Recalls & reported problems
Arthrex, Inc. · 3.0 X 12MM VAL SCREW, Ti · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867050211), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 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 17561555 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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