Arthrex® AR-8933V-28SRecalls & reported problems
Arthrex, Inc. · 3.0 X 28MM VAL SCREW, Ti, STRL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867210332), received between Jun 7, 2023 and Jan 10, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
- Positioning Failure1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Positioning Failure; Positioning Failure
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8933V-28S WAS USED ON A MEDIAL HOOK PLATE, BUT IT DID NOT LOCK. THE CASE WAS COMPLETED BY USING ANOTHER OF THE SAME PRODUCT. HAPPENED DURING A CASE BUT THERE WAS NO HARM OR EFFECT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 12/20/2024: THIS WAS DISCOVERED DURING AN ORIF PROCEDURE. THE CASE WAS COMPLETED BY USING THE SAME AR-9963PLL-04S POSTEROLATERAL DISTAL FIBULA PLATE WITH A NEW AR-8933V-28S LOW PROFILE VA LOCKING SCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21125285 ↗InjuryJun 7, 2023Material Fragmentation; Material Fragmentation
ON 5/15/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8952TS-05S GERADE LOW PROFILE-T-PLATTE, AN AR-8933V-24S LOW PROFILE VA LOCKING SCREW, AN AR-8933V-26S LOW PROFILE VA LOCKING SCREW, AN AR-8933V-28S LOW PROFILE VA LOCKING SCREW, AN AR-8933V-30S LOW PROFILE VA LOCKING SCREW, AND AN AR-8933-30S LOW PRO CORTICAL SCREW WERE REMOVED DURING REVISION SURGERY. AFTER THE ORIGINAL SURGERY, A POSTOPERATIVE X-RAY SHOWED RESIDUAL METAL FRAGMENTS. THIS PROCEDURE TOOK PLACE ON (B)(6) 2023. NO FURTHER INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 17078535 ↗
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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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