ULTRABRAID 7211080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010547675), received between Jan 6, 2021 and Dec 7, 2023 — classified as 2 injuries, 2 malfunctions.

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

• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL ACHILLES TENDON RUPTURE SURGERY WAS PERFORMED ON (B)(6) 2022, AND ON (B)(6) 2023 THE PATIENT SELF-NOTICED REDNESS AND SWELLING AROUND THE WOUND. THE WOUND WAS ADMITTED ON (B)(6) 2023 AND WAS FOUND TO BE RED, SWOLLEN, AND PUS-FILLED. THE ULTRABRAID SUTURE WAS REMOVED ON (B)(6) 2023 (B)(6) . AFTER THAT, A DEBRIDEMENT PROCEDURE WAS PERFORMED FOR TREATMENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Post Operative Wound Infection; Skin Inflammation/ Irritation

  MAUDE report 18284369 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION ON (B)(6) 2020, THE PATIENT´S TENDON WAS SUTURE WITH ULTRABRAID SUTURE. ON (B)(6) 2022, THE INCISION WAS PURULENT, DEBRIDEMENT WAS PERFORMED AND FIXATION PRODUCTS WERE TAKEN OUT. THE PATIENT IS UNDER HOSPITAL OBSERVATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Purulent Discharge

  MAUDE report 14701293 ↗
• MalfunctionJan 6, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE EXPIRY DATE MENTIONED ON THE PACKAGING OF THE ULTRABRAID DID NOT CORRESPOND TO THE DATE INDICATED ON THE DELIVERY NOTE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124930 ↗
• MalfunctionJan 6, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE EXPIRY DATE MENTIONED ON THE PACKAGING OF THE ULTRABRAID DID NOT CORRESPOND TO THE DATE INDICATED ON THE DELIVERY NOTE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124897 ↗