Arthrex® AR-8953-07Recalls & reported problems
Arthrex, Inc. · PLATE, POW, LOCKING, TI, 7 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867055216), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2020Break
IT WAS REPORTED, THE DURING A POST-OPERATIVE FOLLOW-UP ON FOR A PROXIMAL OPEN WEDGE BUNION PROCEDURE ON (B)(6) 2020, X-RAYS SHOWN A BROKEN AR-8953-07, LOCKING PLATE. THE SURGEON REMOVED AR-8953-07, AR-8933-V-16 (2), AR-8933V-18(1) AND AR-8933V-20(1) ON (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 11/11/2020: THE PATIENT'S ORIGINAL SURGERY TOOK PLACE (B)(6) 2020. THERE WAS NO KNOWN OR REPORTED TRAUMA SUFFERED BY THE PATIENT POST-OP. THE REVISION SURGERY TO REMOVE THE BROKEN PLATE AND SCREWS WAS PERFORMED (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 11/12/2020: DURING THE REVISION, UPON EXPLANTATION, IT WAS DISCOVERED THAT THE PLATE AND ONE SCREW WERE BROKEN INSIDE THE PATIENT. IT IS UNKNOWN AT THIS TIME WHICH OF THE SCREW PART NUMBERS: AR-8933-V-16, AR-8933V-18 OR AR-8933V-20 IS THE SCREW THAT WAS BROKEN OR IF THE SCREW MAY HAVE BROKEN DUE TO THE BROKEN PLATE THAT WAS DISCOVERED AT ONE OF THE PATIENT FOLLOW UP VISITS. DURING THE REVISION THERE WERE NO NEW DEVICES IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 10934560 ↗
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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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