Arthrex® AR-1278PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867006911), received between May 3, 2022 and Oct 15, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SURGERY THE STRIPPER CUT THE TENDO TOO SOON. NO FURTHER INFORMATION WAS PROVIDED. UPDATE AVOE 15-OCT-2024: IT WAS FURTHER REPORTED THAT THE ERROR OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) LIGAMENTOPLASTY TYPE 3+2 (DIDT WITH EXTERNAL RETURN). THE SURGERY WAS FINISHED SUCCESSFULLY BY SWITCHING THE SURGICAL TECHNIQUE, BECAUSE THE SURGEON COULDN'T DO THE EXTERNAL RETURN AS THE GRAFT WAS TOO SHORT. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20455635 ↗
• MalfunctionSep 16, 2024Defective Device; Defective Device

  UPDATE AVOR 07-OCT-2024. THE SURGEON STATED THAT THERE WAS NO PARTICULAR EXPLANATION, BECAUSE HE DID EVERYTHING AS USUAL. THE ERROR OCCURRED ON TWO OCCASIONS AND (B)(4) WAS OPENED FOR THE SECOND OCCASION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224604 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A MATERIAL BREAKAGE WITH THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643074 ↗
• MalfunctionMay 3, 2022Dull, Blunt

  ON 04/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1278P TENDON STRIPPER IS DULL. THIS WAS DISCOVERED DURING AN UNKNOWN CASE WHEN THE DEVICE WAS FOUND TO NOT BE SHARP. A SECOND INCISION WAS MADE DUE TO THE LACK OF SHARPNESS.

  Patient problems: Laceration(s)

  MAUDE report 14270271 ↗