Arthrex® AR-9943T-08Recalls & reported problems
Arthrex, Inc. · Locking Third Tubular Plate, Ti, 8H · Class 2 · Implant
Data updated Oct 16, 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 00888867256187), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Loss of fracture reduction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Patient Device Interaction Problem
On 10-Aug-2026, a sales representative reported via email that an AR-9943T-08 Locking Third Tubular Plate, 8 Hole, was involved in an event. During a distal fibula fracture revision procedure performed on (b)(6) 2026, a TightRope Pro was used in conjunction with the plate. It was reported that the TightRope Pro slipped through the plate's oblong hole, resulting in loss of fracture reduction (malreduction). An immediate revision was performed, during which the TightRope Pro was removed, and a 4.0 × 16 mm cancellous screw was implanted for fixation, allowing successful realignment and reduction of the fracture. The patient outcome was not reported.Additional information was received on 19-Aug-2026:The sales representative reported that the AR-9925T Syndesmosis TightRope PRO Implant was used in conjunction with the plate. The TightRope PRO was intentionally implanted through the third hole from the most distal end of the plate. Initial intraoperative imaging reportedly demonstrated an acceptable reduction. However, approximately four hours after wound closure, postoperative radiographs obtained in recovery identified a malreduction. The surgeon's assessment was that the TightRope PRO
Patient problems: Loss of fracture reduction
MAUDE report 50472272 ↗
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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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