ULTRABRAID 72203841Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885554030051), received between Jun 17, 2018 and Jan 14, 2020 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY ON (B)(6) 2019 PATIENT STARTED WITH NEUROPRAXIA AND PAIN, THEREFORE HE WAS TREATED WITH MEDICATION THERAPY AND HOSPITALIZATION WAS PROLONGED AND HE WAS DISCHARGED THE FOLLOWING DAY. THE ISSUE WAS SOLVED WITH SEQUELAE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9588434 ↗
• MalfunctionJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY ON (B)(6) 2019 PATIENT STARTED WITH NEUROPRAXIA AND PAIN, THEREFORE HE WAS TREATED WITH MEDICATION THERAPY AND HOSPITALIZATION WAS PROLONGED AND HE WAS DISCHARGED THE FOLLOWING DAY. THE ISSUE WAS SOLVED WITH SEQUELAE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9587502 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY ON (B)(6) 2019 PATIENT STARTED WITH NEUROPRAXIA AND PAIN, THEREFORE HE WAS TREATED WITH MEDICATION THERAPY AND HOSPITALIZATION WAS PROLONGED AND HE WAS DISCHARGED THE FOLLOWING DAY. THE ISSUE WAS SOLVED WITH SEQUELAE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9587367 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY ON (B)(6) 2019 PATIENT STARTED WITH NEUROPRAXIA AND PAIN, THEREFORE HE WAS TREATED WITH MEDICATION THERAPY AND HOSPITALIZATION WAS PROLONGED AND HE WAS DISCHARGED THE FOLLOWING DAY. THE ISSUE WAS SOLVED WITH SEQUELAE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9586336 ↗
• MalfunctionNov 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ACETABULAR LABRUM REPAIR, ONE SUTUREFIX ULTRA ANCHOR WAS DAMAGED DURING INSERTION. IN CONSEQUENCE, THE ANCHOR WAS PULLED OUT OF THE PATIENT. IT WAS NOT USED ANOTHER DEVICE TO REPLACE IT. IT IS UNKNOWN IF SUCCESSFUL FIXATION WAS ACHIEVED WITH THE OTHER FOUR ANCHORS THAT FUNCTIONED AS INTENDED. BROKEN PIECES WERE REMOVED WITH GRASPERS AND THERE WAS A 2 MINUTES DELAY. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT IS RECOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9347735 ↗
• MalfunctionJun 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SURGERY, THE SUTUREFIX XL ANCHOR INSERTER BROKE OFF IN THE DRILL HOLE ON DEPLOYMENT OF THE ANCHOR. IT WAS THEN RETRIEVED FROM THE HOLE VIA A GRASPER. THE METAL PRONG AND SOME SUTURE WAS RETRIEVED ONCE THE AREA WAS CLEARED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8683495 ↗
• MalfunctionJan 11, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON USED A SUTUREFIX XL ANCHOR DURING A SURGERY. THE CASE WENT WELL AND THE ANCHOR DEPLOYED. HOWEVER, ON THE X-RAY DURING THE PROCEDURE A SMALL MARK WAS VISIBLE ON THE IMAGE. ON FURTHER IMAGING AFTER SURGERY IT APPEARS THAT IT IS A TINY PIECE OF METAL FROM THE ANCHOR (PROBABLY THE INSERTION PRONG). THE PATIENT HAS HAD NO PAIN AND THE METAL PRONG APPEARS TO BE UNDER THE ANCHOR AND IN THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8239218 ↗
• MalfunctionNov 22, 2018Break

  IT WAS REPORTED THAT DURING THE SURGERY THE DEVICE GOT BROKEN. ALL BROKEN THE PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY. BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8098948 ↗
• MalfunctionNov 16, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DEVICE BROKE INSIDE THE PATIENT'S ANATOMY. BROKEN PIECES WERE NOT RETRIEVED AS PER CUSTOMER REPORT. BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8081058 ↗
• MalfunctionJun 17, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF A LABRAL REPAIR WITH A SUTUREFIX ULTA ANCHORS. IT WAS NOTED ON THE X-RAY IMAGE A FOREIGN BODY. IT WAS A PART OF THE ANCHOR DEPLOYMENT DEVICE. THE OBJECT WAS RETRIEVED FROM THE PATIENT. FIVE ANCHORS WHERE USED AND IT IS UNSURE WHICH DEVICE MALFUNCTIONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7608480 ↗
• MalfunctionJun 17, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF A LABRAL REPAIR WITH A SUTUREFIX ULTA ANCHORS. IT WAS NOTED ON THE X-RAY IMAGE A FOREIGN BODY. IT WAS A PART OF THE ANCHOR DEPLOYMENT DEVICE. THE OBJECT WAS RETRIEVED FROM THE PATIENT. FIVE ANCHORS WHERE USED AND IT IS UNSURE WHICH DEVICE MALFUNCTIONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7608477 ↗
• MalfunctionJun 17, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF A LABRAL REPAIR WITH A SUTUREFIX ULTA ANCHORS. IT WAS NOTED ON THE X-RAY IMAGE A FOREIGN BODY. IT WAS A PART OF THE ANCHOR DEPLOYMENT DEVICE. THE OBJECT WAS RETRIEVED FROM THE PATIENT. FIVE ANCHORS WHERE USED AND IT IS UNSURE WHICH DEVICE MALFUNCTIONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7608472 ↗
• MalfunctionJun 17, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER COMPLETION OF A LABRAL REPAIR WITH A SUTUREFIX ULTA ANCHORS. IT WAS NOTED ON THE X-RAY IMAGE A FOREIGN BODY. IT WAS A PART OF THE ANCHOR DEPLOYMENT DEVICE. THE OBJECT WAS RETRIEVED FROM THE PATIENT. FIVE ANCHORS WHERE USED AND IT IS UNSURE WHICH DEVICE MALFUNCTIONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7608466 ↗