ULTRABRAID 7210914Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010511942), received between Jul 15, 2019 and Aug 22, 2025 — classified as 6 injuries, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE ULTRABRAID DISASSEMBLED FROM THE NEEDLE AFTER 2 STITCHES WERE MADE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877038 ↗
• MalfunctionJul 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRABRAID BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE SAME BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668323 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LUMBAR FUSION INTERNAL FIXATION FOR LUMBAR SPONDYLOLISTHESIS WITH INTRAOPERATIVE MUSCLE CLOSURE USING ULTRABRAID SUTURES, AND THE PATIENT WAS DISCHARGED CLINICALLY HEALED. HOWEVER, ON SEPTEMBER 6, 2023, A WOUND ULCER FORMATION WAS NOTED ON THE LOW BACK, AND ON SEPTEMBER 13, A WOUND ULCER DEBRIDEMENT AND SUTURING WAS PERFORMED AND THE WOUND WAS CLOSED. THE PATIENT WAS DISCHARGED WELL HEALED AS OF THE DATE OF THE REPORT, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Ulcer

  MAUDE report 18326731 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN OPEN EXPLORATION, REDUCTION AND INTERNAL FIXATION FOR THE AVULSION FRACTURE OF THE LEFT LATERAL CONDYLE OF THE HUMERUS IN WHICH A KIRSCHNER WIRE AND ULTRABRAID SUTURE WERE USED TO HELP FIX THE FRACTURE END, THE ULTRABRAID SUTURE WAS EXPOSED, AND THE PATIENT WAS TREATED IN THE OUTPATIENT DEPARTMENT. THE SYMPTOMS DID NOT IMPROVE AFTER REPEATED TREATMENT AND THE PATIENT UNDERWENT A DEBRIDEMENT AND EXPLORATION OF THE LEFT ELBOW WOUND AND REMOVAL OF FOREIGN BODIES. DURING THE OPERATION, IT WAS FOUND THAT THE INFLAMMATORY GRANULOMA WRAPPED THE ORIGINAL INTERNAL FIXATION SUPER STRONG SUTURE, AND THE INFLAMMATORY TISSUE AROUND THE SUTURE PROLIFERATED. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 15698685 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "REPAIR INTEGRITY AND FUNCTIONAL OUTCOMES BETWEEN KNOT-TYING AND KNOTLESS SUTURE-BRIDGE ARTHROSCOPIC ROTATOR CUFF REPAIR: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL", ONE PATIENT HAD A POST-OPERATIVE SUPERFICIAL ACTIVE INFECTION AFTER A KNOT-TYING ROTATOR CUFF REPAIR PROCEDURE USING AN ULTRABRAID SUTURE. THIS EVENT WAS TREATED BY ADMINISTRATION OF ORAL ANTIBIOTICS. THE PATIENT WAS FULL RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12896266 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON LITERATURE REVIEW "ARTHROSCOPIC TREATMENT OF FIRST-TIME SHOULDER DISLOCATIONS IN YOUNGER ATHLETES", ONE PATIENT HAD A SUBLUXATION AFTER A ARTHROSCOPIC PROCEDURE USING AN ULTRABRAID SUTURE. NO FURTHER ACTION DUE TO THIS EVENT AND THE PATIENT OUTCOMES IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Subluxation

  MAUDE report 12895068 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "ARTHROSCOPIC TREATMENT OF FIRST-TIME SHOULDER DISLOCATIONS IN YOUNGER ATHLETES", ONE PATIENT HAD A SUPERFICIAL INFECTION AFTER A ARTHROSCOPIC PROCEDURE USING A ULTRABRAID SUTURE. THE EVENT WAS TREATED WITH FIRST-GENERATION CEPHALOSPORIN FOR 7 DAYS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12894589 ↗
• InjuryOct 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE DURING ARTHROSCOPY PROCEDURE, THE TYPE OF GRAFT USED FOR THE SURGERY WAS AUTOLOGOUS HTH WITH A LENGTH OF 85MM AND A DIAMETER OF 10MM EACH BONE PLUG WITH A LENGTH OF 20MM. TO SUSPEND THE GRAFT, THE SPECIALIST DECIDED TO PLACE ENDOBUTTON BTB. IN ORDER TO SUSPEND THIS DEVICE THROUGH THE FEMORAL TUNNEL, THE USE OF STRONG SUTURES WAS NECESSARY. DURING THE SUSPENSION OF THE DEVICE AT THE TIME OF VERIFYING IF THE PLATE WAS ATTACHED TO THE CORTEX, THE ULTRABRITTE SUTURE IS BROKEN IN 2 PARTS. THE PIECES WERE REMOVED. TO COMPLETE THE PROCEDURE, THE DOCTOR MANEUVERED TO FINISH SUSPENDING THE GRAFT UNTIL THE GRAFT WAS PLACED IN THE PROPER SITE WITH THE HELP OF ARTHROSCOPIC FORCEPS. FINALLY, THE SPECIALIST VERIFIED THE TENSION OF THE GRAFT AND ITS FUNCTIONALITY, CONCLUDED BY SAYING THAT IT IS FINE AND FULFILLS ITS FUNCTION. NO FURTHER COMPLICATIONS REPORTED. PATIENT'S CONDITION IS STABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10639526 ↗
• MalfunctionJul 15, 2019Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE KNOTTING WAS BEING MADE THE SUTURE GOT BROKEN, BROKEN SUTURE WAS REMOVED FROM THE PATIENT'S ANATOMY. THE SUTURE WAS REPLACED WITH ANOTHER IN ORDER TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8788778 ↗