ULTRABRAID 7211081Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010547682), received between Sep 17, 2020 and Nov 26, 2025 — classified as 1 injury, 3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A PATELLAR LIGAMENT RECONSTRUCTION+LATERAL RELEASE AND MEDIAL, THE ULTRBRD#2 COBRAID 38 WAS BROKEN, IT WAS IMMEDIATELY REMOVED WITH GRASPER AND TWEEZERS, AND REPLACED WITH AN EQUIVALENT SN BACK UP. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. THE PATIENT'S CONDITION IS STABLE, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659502 ↗
• InjuryJul 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PROCEDURE TO FIX AN ANKLE FRACTURE WITH SEPARATION OF TIBIOFIBULAR SYNDESMOSIS USING AN ULTRABRAID SUTURE, THE PATIENT'S WOUND WAS RUPTURED, EXUDED, PURULENT, AND SWOLLEN FIVE DAYS POST-OP. DEBRIDEMENT WAS PERFORMED AND THE SUTURE WAS REMOVED. PATIENT REQUIRED A PROLONGED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. CURRENT STATUS OF THE PATIENT IS RECOVERED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Purulent Discharge; Rupture; Swelling/ Edema

  MAUDE report 15090732 ↗
• 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 11126093 ↗
• MalfunctionSep 17, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE URGICAL INSTRUMENTALIST BROKE THE PLASTIC WRAP THAT COVERS THE SECONDARY PACKAGING AND WHEN OPENING IT, FOUND THAT THE PRIMARY PACKAGING OF THE PRODUCT WAS OPEN, COMPROMISING THE STERILE CONDITION. THE SECONDARY PACKAGING DID NOT HAVE THE STANDARD SMITH-NEPHEW SEAL, ONLY THE PLASTIC WRAP. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546327 ↗