Arthrex® AR-13280-40Recalls & reported problems
Arthrex, Inc. · SCREW, CANCELLOUS 6.5 X 40MM · 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 00888867010543), received between Apr 12, 2021 and Apr 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED, THAT DURING A DISTAL TIBIAL OSTEOTOMY, AFTER THE AR-13715-09.0, HTO PLATE WAS SEATED, AS THE SURGEON WAS INSERTING THE AR-13280-40, SCREW, IT WAS NOTICED THAT THE BUSHING ON THE PLATE CAME LOOSE. THE SURGEON REMOVED THE PLATE AND SCREW, THE BUSHING WAS ATTACHED TO THE SCREW. THE CASE WAS COMPLETED USING AR-13100.09. THERE WAS 30-45 MINUTES ADDED TO THE PROCEDURE REQUIRING ADDITIONAL ANESTHESIA.
Patient problems: Failure of Implant
MAUDE report 11648284 ↗
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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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