Arthrex® AR-13303-3.0Recalls & reported problems
Arthrex, Inc. · OSTEOTOMY GUIDE PIN, 3.0MM · Class 1
Data updated Oct 18, 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 10888867010717), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2018Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A CASE, THE 3.0 PIN BECAME STUCK IN THE OSTEOTOMY GUIDE. THE SURGEON HAD TO PERFORM A FREE-HANDED CUT TO COMPLETE THE CASE. *ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 8/7/2018: THIS EVENT OCCURRED DURING A DISTAL FEMORAL OPENING WEDGE OSTEOTOMY, THE 3.0 OSTEOTOMY GUIDE PIN, AR-13303-3.0 BECAME STUCK AS THE SURGEON WAS TRYING TO REMOVE IT FROM THE GUIDE. THE DEVICES WERE USED PER DFU TECHNIQUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7827349 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
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- 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
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion Medical Products Corp SUT15830AMedline Industries, Inc. · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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