Arthrex® AR-9943T-06Recalls & reported problems
Arthrex, Inc. · Locking Third Tubular Plate, Ti, 6H · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867256163), received between Jun 13, 2024 and Aug 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Positioning Failure1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2024Positioning Failure; Positioning Failure
ON 07/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-8935L-10 LOW PROFILE LOCKING SCREW WENT STRAIGHT THROUGH THE AR-9943T-06 LOCKING THIRD TUBULAR PLATE. THIS OCCURRED DURING A PROCEDURE, THE 3.5 LOCKING SCREW WENT STRAIGHT THROUGH THE PLATE WITH LITTLE TO NO PRESSURE LIKE HE WASN¿T CRANKING ON THE SCREW IT JUST WENT STRAIGHT THROUGH THE PLATE, WHICH ISN¿T NORMAL. THEY TOOK EVERYTHING OUT AND REPLACED IT WITH ANOTHER AR-9943T-06 IN THE TRAY WHICH HAD NO ISSUES AND USED A NEW AR-8935L-10 SCREW WITH NO ISSUES.
Patient problems: Insufficient Information
MAUDE report 19927320 ↗MalfunctionJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 04/03/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA PHONE THAT AN AR-9943T-06 LOCKING THIRD TUBULAR PLATE WOULD NOT THREAD A SCREW. THIS OCCURRED DURING AN ANKLE FRACTURE AFTER INSERTING THE PLATE ON THE LEFT ANKLE FIBULAR THEY INSERTED A COUPLE OF SCREW USING A CREW LOCK SCREW IT WENT STRAIGHT THROUGH THE PLATE AND DID NOT ENGAGE THROUGH THE THREADS. THE SCREWS AND PLATE WERE REMOVED AND ANOTHER AR-9943T-06 FROM A DIFFERENT LOT WAS USED AND WORKED ACCORDINGLY TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19533013 ↗
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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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