PERMATAPE 223165Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705027859), received between Oct 22, 2020 and Jul 2, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2, 2024Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE PERMATAPE 2.5 BLUE DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657507 ↗
• InjuryAug 31, 2023Break; Break

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2023 TREATING AN ACL TEAR. ACCORDING TO THE REPOT, A PERMATAPE SUTURE, BLUE BRAIDED FLAT SUTURE, 2.5MM (6 PACK) DEVICE WAS USED THAT BROKE POSTOPERATIVELY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A RE-OPERATION/REVISION PROCEDURE FOR LOOSE BODY REMOVAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17662386 ↗
• MalfunctionOct 22, 2020Migration; Migration

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR TWO OF THE 4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR ALONG WITH ONE PERMATAPE SUTURE, BLUE BRAIDED FLAT SUTURE, 2.5MM PULLED OUT. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 10718369 ↗