Arthrex® AR-9670-1Recalls & reported problems
Arthrex, Inc. · BONE GRAFT PREPARATION STATION, BASE · 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 00888867324831), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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.
Most reported problems
Device problems
- Material Too Rigid or Stiff1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Material Too Rigid or Stiff; Mechanical Jam
IT WAS REPORTED THAT DURING A REVERSE BONE GRAFT SURGERY A SCREW FOR ADJUSTING THE SAW ANGLE OF THE DEVICE WAS STUCK IN THE THREAD. THE SCREW COULDN`T BE LOOSENED AGAIN WITH PLIERS. NO PART OF THE DEVICE BROKE OFF. THE SURGEON HAS FINISHED THE SURGERY SUCCESSFULLY FREEHAND. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12268542 ↗
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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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