Arthrex® ABS-8000-06Recalls & reported problems
Arthrex, Inc. · OSTEOAUGER BONE GRAFT HARVESTER, 6MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867377042), received between Jun 13, 2022 and Mar 21, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
- Physical Resistance/Sticking1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 05/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE SURGEON WAS UNABLE TO UNTWIST/TAKE APART THE DEVICE TO RETRIEVE THE ABS-8000-06 BONE GRAFT. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW ABS-8000-06 WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18952662 ↗InjuryJun 13, 2022Inadequacy of Device Shape and/or Size
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE HARVESTING BONE FROM THE CALCANEUS OF A PATIENT USING AN ABS-8000-06 8MM OSTEO-AUGER, PATIENT EXPERIENCED BONE BURNING. SURGEON DOWN SIZED TO A 6MM OSTEO-AUGER AND WAS ABLE TO COMPLETE THE DESIRED DIAMETER ALONG WITH SALINE IRRIGATION TO DECREASE THE AMOUNT OF BONE BURNING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14674272 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page