PERMATAPE 280782Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705032792), received between Dec 11, 2024 and Jul 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A QUADRICEPS TENDON REPAIR SURGICAL PROCEDURE FOR A QUADRICEPS TENDON TEAR, IT WAS OBSERVED THAT WHILE USING THE PERMATAPE 1.3 W/B OS6 NDL1PK DEVICE, AT THE TIME OF MAKING A KNOT, THE PERMATAPE DEVICE SNAPPED EVEN THOUGH THE SURGEON DID NOT APPLY STRONG TENSION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO FOREIGN OBJECTS LEFT IN THE BODY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542194 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR (ARCR) PROCEDURE, IT WAS OBSERVED THAT THE PERMATAPE 1.3 W/B OS6 NDL1PK SUTURE DEVICE BROKE MIDWAY THROUGH AND COULD NO LONGER BE USED. IT WAS REPORTED THAT THERE WAS NO RESIDUE OF THE DEVICE LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941941 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT AFTER THE PERMATAPE 1.3 W/B OS6 NDL DEVICE PASSED THROUGH THE TISSUE, THE TAPE BROKE DURING SUTURING. IT WAS REPORTED THAT THERE WAS NO SITUATION THAT WOULD HAVE DAMAGED THE TAPE. ANOTHER LIKE DEVICE WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY, NO PIECES LEFT IN THE BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909800 ↗