Arthrex® AR-8735BV-50Recalls & reported problems
Arthrex, Inc. · 3.5x50mm Beveled FT Screw · Class 2 · Implant
Data updated Oct 16, 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 00888867360952), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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 Damaged by Another Device1
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.
MalfunctionMar 20, 2026Device Damaged by Another Device
ON 02-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8741-40 T10 BEVELED HEXALOBE DRIVER SHAFT BROKE OFF INTO THE HEAD OF THE SCREW WHEN INSERTING INTO PATIENT DURING A METACARPAL FX PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAR-2026. THE REP ADVISED THAT THE SURGEON USED A HANDLE (AR-8700RH) ATTACHED TO THE DRIVER SHAFT (AR-8741-40) TO INSERT THE SCREW BY HAND. THEY STATED THE SURGEON USED A 1.4MM GUIDE WIRE (AR-8741-14), AS WELL AS A 2.9MM DRILL BIT (AR-8741-25) TO PREP THE BONE FOR THE INSERTION OF THE SCREW. THE SURGEON WAS NOT ABLE TO USE THE DRIVER SHAFT (AR-8741-40) TO REMOVE THE SCREW SINCE THE DRIVER SHAFT BROKE OFF INTO THE HEAD OF THE SCREW (AR-8735BV-50). THEY WERE ABLE TO USE INSTRUMENTS THE HOSPITAL OWNED TO RETRIEVE THE REMAINING PIECES OF THE DRIVER SHAFT OUT OF THE HEAD OF THE SCREW. THEY THEN USED A DIFFERENT DRIVER SHAFT TO REMOVE THE SCREW (AR-8735BV-50), THEY RE-DRILLED WITH AN AR-8741-25, AND INSERTED AN AR-8735BV-48, WHICH WAS IMPLANTED USING A DIFFERENT DRIVER SHAFT. THE SURGEON USED THE 3.5MM BEVELED SCREWS, IMPLANTED/EXPLANTED AR-8735BV-
Patient problems: Insufficient Information
MAUDE report 24650155 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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