Arthrex® AR-8964-04Recalls & reported problems
Arthrex, Inc. · 5.0mm Self Drill Schanz Screw, 200mm, SS · 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 00888867241138), received between Apr 22, 2026 and Apr 22, 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.
InjuryApr 22, 2026Patient Device Interaction Problem
ON 01-APR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT SEVEN AR-8964-07 LARGE COMBINATION CLAMPS, FOUR AR-8964-27 STRAIGHT ATTACHMENT ARMS, TWO AR-8964-08 MULTI-PIN CLAMPS (LARGE), AND THREE AR-8964R-450 CARBON RODS (450 MM) WERE USED IN A KNEE-SPANNING EXTERNAL FIXATION CONSTRUCT WITH THE ARTHROFX EXTERNAL FIXATION SYSTEM DURING A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2026. THE CONSTRUCT INCLUDED TWO 5 MM ARTHROFX SCHANZ PINS PLACED IN THE FEMUR AND TWO 5 MM ARTHROFX SCHANZ PINS PLACED IN THE TIBIA TO ADDRESS A PROXIMAL TIBIAL FRACTURE. INTRAOPERATIVELY, THE SURGEON APPLIED DISTRACTION, BROUGHT THE FRACTURE TO LENGTH, TIGHTENED ALL COMBINATION CLAMPS, AND COMPLETED THE PROCEDURE WITHOUT ISSUE. WITHIN APPROXIMATELY 36¿48 HOURS POSTOPERATIVELY, FOLLOW-UP X-RAY IMAGING DEMONSTRATED LOSS OF FRACTURE REDUCTION, AND THE EXTERNAL FIXATOR WAS NOTED TO HAVE SLIPPED. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2026. DURING THE REVISION, THE SURGEON INITIALLY ATTEMPTED TO REUSE THE EXISTING ARTHROFX 5 MM SCHANZ PINS; HOWEVER, WHEN DISTRACTION WAS APPLIED USING AN ALTERNATE MANUFACTURER¿S COMBINATION CLAMPS, INTRAOPERATIVE X-RAY IMAGING DEMONSTRATED BENDING OF THE ARTHROF
Patient problems: Loss of fracture reduction
MAUDE report 24952608 ↗
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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