Arthrex® AR-8935CL-16Recalls & reported problems
Arthrex, Inc. · KreuLock Screw, Ti, 3.5x16 · 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 00888867323094), received between Jun 7, 2024 and Jun 7, 2024 — 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.
MalfunctionJun 7, 2024Positioning Failure; Positioning Failure
ON 11/9/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935CL-16 KREULOCK SCREW WENT RIGHT THROUGH AN AR-9943T-07LOCKING THIRD TUBULAR PLATE DURING INSERTION. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2022. SURGEON BACKED THE SCREW OUT A FEW TURNS AND LEFT IT IMPLANTED IN THE PATIENT. IT IS NOW ACTING A NON-LOCKING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487173 ↗
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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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