Arthrex® AR-9943BL-05Recalls & reported problems
Arthrex, Inc. · Locking Distal Fibula Plate, Ti ,Left,5H · Class 2 · Implant
Data updated Oct 18, 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 00888867255616), received between Aug 4, 2025 and Aug 4, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionAug 4, 2025Positioning Failure; Positioning Failure
ON 7/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT ONE AR-8933V-14 LOW PROFILE VA LOCKING SCREW, ONE AR-8933V-16 LOW PROFILE VA LOCKING SCREW, AND TWO AR-8933V-18 LOW PROFILE VA LOCKING SCREWS WERE UNSUCCESSFULLY THREADED THROUGH A LOCKING DISTAL FIBULAR PLATE, DESPITE APPROPRIATE DRILLING TECHNIQUES. AS A RESULT, ALL FOUR SCREWS WERE DISCARDED, AND THE PLATE HOLE REMAINED UNFILLED. THIS WAS DISCOVERED DURING AN ORIF ANKLE PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/21/2025: ON (B)(6) 2025, DURING AN ORIF ANKLE PROCEDURE, AN AR-9943BL-05 LOCKING DISTAL FIBULA PLATE WAS IMPLANTED AND REMAINS IN THE PATIENT. THERE WAS NO REPORT OF IMPLANT BREAKAGE DURING THE INCIDENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 10 MINUTES DUE TO DIFFICULTY ENGAGING THE SCREWS, WHICH REQUIRED REDRILLING AND REINSERTION. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO ACCOMMODATE THE EXTENDED OPERATIVE TIME. AN AR-8933GV DRILL GUIDE AND AN AR-8943-16 2.0 MM DRILL BIT WERE USED TO PREPARE THE BONE SOCKET FOR IMPLANT PLACEMENT. BONE QUALITY WAS ASSESSED AS ADEQUATE, AND NO PHOTOGRAPHS WERE TAKEN TO DOCUMENT THE ISSUE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22698660 ↗
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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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