Arthrex® AR-4095SRecalls & reported problems
Arthrex, Inc. · OSTEO FLAP REPR MULTI SHOT INSTRS · Class 1
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 00888867032705), received between Jun 4, 2024 and Jun 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED ON 08/31/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-4095S CAME APART FROM THE DRILL, AN AR-1204FF FLIPCUTTER DRILL BIT BROKE OFF DURING DRILLING AND AN AR-8737-37 DRIVER HEAD BROKE OFF IN THE SCREW HEAD. THIS WAS DISCOVERED DURING A CASE AND THE FLIPCUTTER AND THE DRIVER HEAD BROKE OFF INSIDE THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19457491 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
- Arthrex® AR-13995NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE430 reports
- Arthrex® AR-12990NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE197 reports
- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Medline Industries, Inc. DYNJ901391DMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 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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