Arthrex® AR-1278LRecalls & reported problems
Arthrex, Inc. · STRIPPER SEMITENDINOSUS, 7MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867006904), received between Dec 18, 2023 and Jun 14, 2024 — classified as 5 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. 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
- Dull, Blunt3
- Corroded1
- Failure to Cut1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Corroded; Corroded
IT WAS REPORTED BY AN ARTHREX EMPLOYEE THAT THERE IS RUST ON THE LASER MARKINGS. 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 19535525 ↗MalfunctionMay 20, 2024Dull, Blunt; Dull, Blunt
ON 6/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1278L SEMITENDINOSUS STRIPPER TIP IS DULL. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351905 ↗MalfunctionMay 20, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE DEVICE IS BLUNT. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19350744 ↗MalfunctionJan 19, 2024Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION WAS PROVIDED ON 01/15/2024, WHERE IT WAS STATED THAT THIS EVENT OCCURRED DURING A KNEE SURGERY ON (B)(6) 2023 WHERE A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18547562 ↗MalfunctionDec 18, 2023Dull, Blunt; Dull, Blunt
ON 11/20/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4), THAT AN AR-1278L SEMITENDINOSUS STRIPPER LOST ITS EDGE AND DOES NOT CUT THE GRAFT, THE EDGE OF THE STRIPPER IS VERY SOFT THAT IS WHY IT DOES NOT CUT CORRECTLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18348383 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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