Arthrex® AR-8916VNR-05Recalls & reported problems
Arthrex, Inc. · VOLAR DISTAL RAD PLT TI NARROW RT 5H · Class 2 · Implant
Data updated Oct 18, 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 00888867130944), received between May 2, 2024 and May 2, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
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 2, 2024Defective Device; Defective Device
ON 04/12/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-8916VNR-05 VOLAR DISTAL RADIUS PLATE IS NOT LOCKING WITH THE SCREWS. THIS OCCURRED DURING AN UNKNOWN CASE WHEN THE SURGEON WAS ABLE TO PASS 2 OF THE DISTAL SCREWS ALL THE WAY THROUGH THE PLATE TO THE OTHER SIDE. THE SCREWS DID NOT LOCK INTO THE PLATE. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19228870 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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