Arthrex® AR-1278PLRecalls & reported problems
Arthrex, Inc. · MINIMALLY INVASIVE GRAFT HARVESTER, OPEN · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867006928), received between May 24, 2024 and Jun 18, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE DEVICE IS BLUNT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19562026 ↗MalfunctionMay 24, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE DEVICES ARE DULL. NO ADDITIONAL INFORMATION AS TO WHAT FAILURE MODE OCCURRED WAS PROVIDED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19393613 ↗MalfunctionMay 24, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE DEVICES ARE DULL. NO ADDITIONAL INFORMATION AS TO WHAT FAILURE MODE OCCURRED WAS PROVIDED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19393535 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.