Arthrex® AR-8943TH-05SRecalls & reported problems
Arthrex, Inc. · LOCKING LATERAL HOOK PLATE, 5H, STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867196391), received between May 24, 2024 and May 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fitting 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.
Reports received per month
Most reported problems
Device problems
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT DURING AN ANKLE FRACTURE SURGERY THE 2.7MM LOCKING SCREWS WERE INSERTED INTO DISTAL HOLES OF LATERAL FIBULA HOOK PLATE. FOUR SCREWS DID NOT LOCK INTO THE PLATE. THE SCREW HEADS WERE FLUSH WITH THE PLATE BUT JUST KEPT SPINNING. THE SURGEON MANAGED TO GET ONE 2.7MM SCREW IN AND AS THE TINES OF THE HOOK WERE SECURE IN THE BONE, HE FELT IT WAS SECURE ENOUGH HELD IN PLACE WITH THE 3.5MM SCREWS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391068 ↗
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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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