ULTRABRAID 72203854Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00885554030044), received between Aug 22, 2017 and Apr 7, 2026 — classified as 37 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (39 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 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA ANCHOR GOT PULLED OUT AFTER DEPLOYMENT DURING TIGHTENING. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800162 ↗
• MalfunctionFeb 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BANKART ARTHROSCOPY, ONE (1) SUTUREFIX ANCHOR CAME OUT IMMEDIATELY ALONG WITH THE SLEEVE AFTER DEPLOYMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. A NEW BONE HOLE WAS DRILLED AT ADJACENT LOCATION. NO VOID LEFT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24245662 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, IT WAS NOTICED THAT WHILE TENSIONING, THE SUTUREFIX KNOT ANCHOR CAME OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23778757 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, IT WAS NOTICED THAT WHILE TENSIONING, THE SUTUREFIX KNOT ANCHOR CAME OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23778151 ↗
• MalfunctionSep 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, WHEN LOWERING THE THREAD OF THE SUTUREFIX, THE SPECIALIST APPLIED TRACTION OR TENSION TO THE THREAD AND IT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144136 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA HAD A BREAKAGE. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936021 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA HAD A BREAKAGE. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935384 ↗
• MalfunctionAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION, THE SUTUREFIX ULTRA GUIDE ANCHOR CAME OUT OF THE BONE HOLE AFTER THE IMPLANT WAS IMPACTED AND UNTIL IT REACHED THE TOP OF THE GUIDE, RIGHT AFTER THE MECHANISM WAS ACTIVATED AND THE STEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE ON AN ADDITIONAL DRILLED BONE HOLE AND LEAVING A VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO DAMAGE OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22901029 ↗
• MalfunctionAug 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO(2) SUTUREFIX ULTRA ANCHORS MALFUNCTIONED IN THE SAME WAY. AFTER INSERTION AND TESTING, THE ANCHORS CAME OUT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN AN ADDITIONAL BONE HOLE. A VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22696722 ↗
• MalfunctionAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN TYING THE THREADS OF ONE (1) SUTUREFIX ULTRA IMPLANT, IT CAME LOOSE, THE IMPLANT WAS SUCCESSFULLY REMOVED, AND IT WAS NOT NECESSARY TO USE ANY TECHNIQUE TO REMOVE IT, SINCE IT CAME OUT ON ITS OWN. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES, WITH A S+N BACK-UP DEVICE. IT WAS NECESSARY TO MAKE A LATERAL PERFORATION TO THE ONE ORIGINALLY MADE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Perforation

  MAUDE report 22686879 ↗
• MalfunctionJun 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ANCHOR CAME OUT POST DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES, USING A SMITH AND NEPHEW BACK UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22332045 ↗
• MalfunctionJun 3, 2025Break; Premature Activation; Material Twisted/Bent; Break; Premature Activation; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A LABRAL LESION PROCEDURE, THE SURGEON NOTICED THAT THE SUTUREFIX ULTRA ANCHOR WAS LOOSE WHEN IT WAS BEING INSERTED INTO THE PATIENT. IT WAS REMOVED FROM THE PATIENT´S CAVITY, AND THE SURGEON NOTICED THAT IT WAS RELEASED WITHOUT BEING INSERTED INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137944 ↗
• MalfunctionMay 23, 2025Failure to Fire; Mechanical Jam; Failure to Fire; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SUTURE FIX DIDN'T DEPLOYED, IT WAS STUCK INSIDE THE BONE ANCHOR, IT WAS REMOVED FROM THE BONE WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED WITH SMITH AND NEPHEW BACK UP DEVICE , ON AN ADDITIONAL BONE HOLE WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22079520 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE THREAD INSIDE TWO ANCHORS STOCKING WERE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667238 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTUREFIX ANCHOR'S TIP GOT BROKEN WHILE TAPPING INTO THE BONE, THE BROKEN PIECES WERE REMOVED USING A GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, ANOTHER BONE HOLE WAS MADE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21649450 ↗
• MalfunctionDec 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA ANCHOR CAME OUT WHILE TENSIONING THE KNOT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE BY MAKING AN ADDITIONAL BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21048084 ↗
• MalfunctionDec 8, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA SUTURE GOT CUT WHILE SURGEON WAS PUTTING KNOT FOR LABRAL REPAIR. SURGERY WAS COMPLETED WITH ANOTHER SUTUREFIX ULTRA ANCHOR TO FINISH THE REPAIR. 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 20875405 ↗
• MalfunctionSep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR CAME OUT WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN AN ADDITIONAL BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20316470 ↗
• MalfunctionSep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR CAME OUT WHILE THE KNOT WAS TIGHTENING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD IN AN ADDITIONAL BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20315736 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR HAD A BREAKAGE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161029 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR CAME OUT WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19746772 ↗
• InjuryJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A GLENOID ANTERIOR LABRUM TEAR PROCEDURE, WHILE TIGHTENING THE KNOT IMPLANT OF THE SUTUREFIX IT CAME BACK OUT FROM GLENOID BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. DEBRIDEMENT DONE AND REMOVED LOOSE BODIES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19501870 ↗
• InjuryMay 30, 2024Unstable; Unstable

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY, THE IMPLANT OF THE SUTUREFIX ULTRA WAS LOOSEN AND CANNOT BE DEPLOYED ANYMORE AFTER DRILLING THE BONE HOLE AND AFTER READJUSTED THE SPOT FOR FEW TIME IN AND OUT FROM THE GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE, DRILLING AN ADDITIONAL BONE HOLE. PATIENT HAVE GENERAL BONE QUALITY, A VOID WAS LEFT IN THE PATIENT AND A SUTUREFIX DRILL GUIDE WAS USED TO PREPARE THE INSERTION SITE. NO DEBRIS CLEARED BEFORE INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19425503 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE-FIX HAD A BREAKAGE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493119 ↗
• InjuryDec 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ANCHOR CAME OUT WHILE TIGHTENING THE KNOT. IT WAS SUCCESSFULLY REMOVED WITH THE HELP OF A GRASPER. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18347619 ↗