Arthrex® AR-8933V-10SRecalls & reported problems
Arthrex, Inc. · 3.0 X 10MM VAL SCREW, TI, STRL · 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 00888867210240), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
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.
MalfunctionJan 8, 2026Positioning Failure
ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT TWO DISTAL SCREWS, AR-8933V-10S LOW PROFILE VA LOCKING SCREW (3 X 10 MM) AND AR-8933V-12S LOW PROFILE VA LOCKING SCREW (3 X 12 MM), FAILED TO LOCK AND ROTATED FREELY WHEN USED WITH A LATERAL HOOK PLATE. NO BREAKAGE OCCURRED. ALTHOUGH FOUR SCREWS WERE PLANNED, THE PROCEDURE WAS COMPLETED WITH ONLY TWO SCREWS INSERTED. THE AFFECTED SCREWS WERE NOT IMPLANTED. THERE WAS NO SIGNIFICANT SURGICAL DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE PATIENT EFFECTS REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2025: THE ISSUE OCCURRED WHILE THE DEVICE WAS INSIDE THE PATIENT. THERE WAS NO CROSS-THREADING OR STRIPPING REPORTED ON THE TWO DISTAL SCREWS, WHICH WERE REMOVED WITHOUT DIFFICULTY. NO DAMAGE WAS OBSERVED ON THE LATERAL HOOK PLATE, AND THE INITIAL LATERAL HOOK PLATE REMAINED IMPLANTED. NO ADDITIONAL SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004220 ↗
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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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