Arthrex® AR-8943DR-05Recalls & reported problems
Arthrex, Inc. · LOCK DISTAL FIBULA PLT, SS RT, 5H · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867346895), received between Nov 28, 2023 and Feb 25, 2025 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fitting Problem1
Patient problems
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2025Break; Break
UPDATE DW 08-APR-2025: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL PROVIDED PART AND LOT NUMBER WAS INCORRECT AND THEREFORE THE DEVICE INFORMATION WAS UPDATED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21459644 ↗MalfunctionNov 28, 2023Fitting Problem; Fitting Problem
ON 11/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DISTAL LOCKING SCREW WOULD NOT LOCK INTO AN AR-8943DR-05 RIGHT LOCKING DISTAL FIBULA PLATE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/2/2023: THIS WAS DISCOVERED DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE ANKLE. TWO AR-8827CL-12 KREULOCK COMPRESSION SCREW AND AN AR-8827CL-16 KREULOCK COMPRESSION SCREW DID NOT LOCK INTO THE PLATE. THE CASE WAS COMPLETED USING ONE OF THE AR-8827CL-12 KREULOCK COMPRESSION SCREWS, OTHER LARGER SCREWS, AND A NEW AR-8943DR-05 RIGHT LOCKING DISTAL FIBULA PLATE. PER THE SALES REPRESENTATIVE, THE DISTAL LOCKING HOLES LOOKED OFF, AND ALTHOUGH IT WAS HARD TO TELL IF IT WAS BEFORE INSERTING THE SCREWS, BUT THE LOCKING TOWER WAS HAVING DIFFICULTY LOCKING ONTO THE PLATE IN THE CORRECT TRAJECTORY. ADDED THE PEEK AIMING GUIDE ONTO THE PLATE TO GET THE CORRECT TRAJECTORY, AND THE LOCKING TOWER WAS STILL HAVING DIFFICULTY THREADING INTO THE PLATE AND AS WELL AS HAVING THE SCREWS SEAT PROPERLY.
Patient problems: Insufficient Information
MAUDE report 18221386 ↗
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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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