ULTRABRAID 72203842Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885554031553), received between Mar 19, 2018 and Nov 13, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUTUREFIX DEVICE LEFT THE METAL ATTACH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PER PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE DISTAL TIP OF THE ACTUATOR BAR IS FRACTURED AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120817 ↗
• InjuryOct 26, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUTUREFIX ULTRA WAS BROKEN IN THE HOLE. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12695122 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT AFTER A LEFT HIP ARTHROSCOPY, THE SUTURE ANCHOR INTRODUCER WAS FOUND BROKEN IN THE BONE. THREE LOT NUMBERS WERE PROVIDED (50621753, 50566979, 50608909) BUT IT IS UNKNOWN WHICH ONE IS THE ONE THAT BROKE. THE BROKEN ANCHOR GUIDE PIECE IDENTIFIED IN LEFT HIP. THE IMPLANT WAS LEFT IN SITU AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12304812 ↗
• InjuryJun 17, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A HIP LABRUM SUTURE SURGERY PROCEDURE, TWO SUTUREFIX ULTRA AHR XL 2 UB BLUE/ WH BROKE DURING THE IMPLANTATION SINCE THE MECHANISM DID NOT ALLOW THE ANCHORS TO BE RELEASED. PROCEDURE FINISHED WITH TWO SUTUREFIX BACKUP IMPLANTS WITH NO DELAY. THE PATIENT WILL BE HOSPITALIZED AGAIN BECAUSE THERE IS A RESIDUAL FOREIGN BODY IN HER HIP.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12015852 ↗
• InjuryJun 17, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRUM SUTURE SURGERY PROCEDURE, TWO SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH BROKE DURING THE IMPLANTATION SINCE THE MECHANISM DID NOT ALLOW THE ANCHORS TO BE RELEASED. PROCEDURE FINISHED WITH TWO SUTUREFIX BACKUP IMPLANTS WITH NO DELAY. THE PATIENT WILL BE HOSPITALIZED AGAIN BECAUSE THERE IS A RESIDUAL FOREIGN BODY IN HER HIP.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12015851 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY, AFTER DRILLING, THE ANCHOR WAS INSERTED, UNLOCKED AND SET. DOCTOR NOTICED THAT THE SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH BROKE OFF IN THE JOINT. THERE WAS NO SURGICAL DELAY. THE METAL COULD NOT BE REMOVED, AFTER X-RAY CONTROL IT WAS FOUND THAT PARTS OF THE ANCHOR ARE IN THE JOINT, PATIENT WAS OPERATED AGAIN ON (B)(6) 2021 AND ALL THE REMAINING BROKEN PARTS COULD BE REMOVED. NO OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN THE PATIENT OUTCOME. 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 11572371 ↗
• MalfunctionApr 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY LABRAL REPAIR SURGERY, THE ANCHOR WAS IMPLANTED BUT IT DID NOT GET A GOOD GRIP BECAUSE OF POOR BONE QUALITY. A BACKUP WAS USED IN AN ADDITIONAL BONE HOLE. NO DELAY OR 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 9999259 ↗
• MalfunctionMar 19, 2018Break

  IT WAS REPORTED THAT THE SUTURE FIX XL ANCHOR WAS PLACED IN ACETABULAR RIM. UPON REMOVAL OF IMPLANT INSERTER AN X-RAY WAS TAKEN. THE TWO PRONGS ON THE DISTAL TIP OF THE IMPLANT INSERTER BROKE OFF AND WERE EMBEDDED IN THE PATIENT¿S BONE. SURGEON ATTEMPTED TO REMOVE THE BROKEN PIECE BUT IT WAS TOO FAR INTO BONE SO IT WAS LEFT. UNSURE OF HOW THE INSERTER BROKE. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7349017 ↗