Arthrex® ABS-4080DRecalls & reported problems
Arthrex, Inc. · Disposables Kit for BioUni · Class 2
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 00888867280502), received between Mar 2, 2021 and Mar 2, 2021 — 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.
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
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.
MalfunctionMar 2, 2021Break; Physical Resistance/Sticking
IT WAS REPORTED DURING A BIOUNI OCA CASE; AFTER SIZING THE INITIAL GRAFT TO A S14, THE DISPOSABLE BIOUNI KIT ((B)(4)) WAS OPENED. THE FIRST THING THE SURGEON DID WAS TRY TO SNAP IN THE POLY INSERT. THE INSERT WOULD NOT SNAP INTO THE METAL OBLONG CUTTER. HE TRIED COMPRESSING THE TABS ON THE POLY. NOTHING. HE PUSHED ON THE POLY WITH A BLUNT INSTRUMENT. NOTHING. HE EVEN LIGHTLY TAPPED THE POLY WITH A MALLET, AND IT WOULD NOT SEAT INTO THE CUTTER. ULTIMATELY, THE SURGEON DECIDED TO CUT OFF THE TAB ON THE POLY SO IT WOULD SEAT ALL THE WAY INTO THE TOP OF THE CUTTER. IF NOT, THE CUTTER WOULD NOT HAVE GONE ALL THE WAY DOWN ONTO THE GRAFT SURFACE WHICH WOULD HAVE LED TO A BAD CUT. THIS WAS CHALLENGING BECAUSE IT KEPT TRYING TO FALL OUT EVERY TIME HE RE-POSITIONED.THE REP STATED THE POLY ALWAYS WENT EASILY (LIGHT THUMB PRESSURE) INTO THE CUTTER PRIOR TO IT BEING A DISPOSABLE INSTRUMENT. THE SURGEON MALLETED THE CUTTER INTO THE GRAFT SUCCESSFULLY WITH THE GOLD HANDLE. HE REMOVED THE HANDLE AND INSERTED THE AR-8916-25 THREADED EXTRACTOR WITH THE BLUE HANDLE CONNECTED INTO THE BACK OF THE CUTTER. THE REP NOTICED AFTER ABOUT HALFWAY DOWN THE SURGEON STARTED GETTING RESISTANCE. THE REP ADVISED H
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11398205 ↗
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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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