PERMATAPE 280779Recalls & reported problems
Medos International Sàrl · PERMATAPE Suture Blue Braided Tape OS-6 36mm 1/2c Reverse Cutting 1.3mm 36" (91cm) · Class 2 · Implant
All models of PERMATAPE (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705032761), received between Jun 19, 2025 and Jul 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Delivered as Unsterile Product1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE NURSE WAS ABOUT TO OPEN THE PACKAGING OF THE PERMATAPE 1.3 BLU OS6 NDL 1PK DEVICE AT THE SURGEON¿S INSTRUCTION, IT WAS OBSERVED THAT THE PACKAGING WAS ALMOST COMPLETELY OPENED. IT WAS REPORTED THAT THE DEVICE WAS NOT USE, AND ANOTHER DEVICE WAS OPENED TO SUCCESSFULLY 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 22634203 ↗MalfunctionJun 19, 2025Break; Break
IT WAS REPORTED THAT DURING A UNITE SURGICAL PROCEDURE WHILE USING THE PERMATAPE 1.3 BLU OS6 NDL 1PK DEVICE, THE SUTURE SNAPPED DURING TYING. SINCE THE SUTURE SNAPPED AFTER A HEAD WAS INSTALLED, IT WAS DIFFICULT TO PASS THE SUTURE BETWEEN THE COLLAR AND HEAD, BUT THE SURGEON MANAGED TO COMPLETE IT WITHOUT ANY PROBLEMS. THERE SURGERY TIME WAS EXTENDED BUT NO MORE THAN THIRTY MINUTES. 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 22289733 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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