ULTRABRAID 72203853Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00885554031447), received between Sep 29, 2017 and Feb 10, 2026 — classified as 29 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR, WHILE TENSIONING THE KNOT OF ONE (1) SUTUREFIX ULTRA, THE ANCHOR CAME OUT FROM THE BONE. ANOTHER BONE HOLE WAS MADE AND PLACED ANOTHER ANCHOR. NO VOID LEFT. THE PATIENT'S STATUS IS GOOD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24307004 ↗
• MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN INSTABILITY PROCEDURE WHILE KNOTTING, THE SUTUREFIX ULTRA AHR S 2 UB STR CB BLU GOT BACKOUT FROM GLENOID BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864014 ↗
• 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 23778515 ↗
• 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 23778049 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE SUTUREFIX ULTRA ANCHOR BROKE WHILE INSERTING INTO THE DRILLED HOLE. 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 22727529 ↗
• MalfunctionMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTUREFIX ANCHOR TIP GOT PULLED OUT FROM THE BONE WHILE TENSIONING THE KNOT. 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 22067351 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, DURING THE KNOT TYING PROCEDURE, THE SUTURE THREADS OF THE SUTUREFIX ULTRA ANCHOR BROKE, SO IT DID NOT DEPLOY PROPERLY, THE SURGEON REMOVED IT FROM THE PATIENT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445450 ↗
• MalfunctionDec 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA AHR GOT PULLED OUT FROM THE BONE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING AN ADDITIONAL BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20838778 ↗
• InjuryOct 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX IMPLANT SUTURE GOT CUT WHILE TYING THE KNOT. THE ANCHOR WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 20544823 ↗
• MalfunctionAug 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA HAD A DEPLOYMENT ISSUE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927874 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE, WHILE TIGHTENING THE KNOT, THE SUTUREFIX IMPLANT BROKE FROM THE GLENOID BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS 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 19907659 ↗
• InjuryApr 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR BROKE WHILE TAPPING INTO THE BONE. THE ANCHOR WAS REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN A NEW BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19165231 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE TAPPING INTO THE BONE THE ANCHOR OF THE SUTUREFIX, IT GOT BROKEN. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS 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 19116032 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SUTUREFIX ULTRA ANCHOR HAD A BREAKAGE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY . NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080495 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR BROKE AFTER BEING DEPLOYED INTO THE BODY. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 18922447 ↗
• InjuryFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SUTUREFIX ULTRA WAS PULLED OUT AFTER THE FULL INSERTION. ANOTHER BONE HOLE WAS DRILL ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE A BACKUP FROM THE SAME REFERENCE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18712919 ↗
• MalfunctionJan 30, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUFERIX ULTRA ANCHOR FAILED TO DEPLOY AND WAS PULLOUT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607774 ↗
• 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 18493095 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA BROKE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS 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 18492008 ↗
• InjuryDec 13, 2023Device 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 ANCHOR WAS REMOVED FROM THE BONE WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE USING ANOTHER DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18320680 ↗
• InjurySep 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER THE SUTUTERFIX ULTRA WAS PLACED BONE HOLE; WHEN THE ANCHOR WAS BEING TIED, IT CAME OUT FROM THE GLENOID. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN AN ADDITIONAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 17724156 ↗
• MalfunctionAug 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SUTUREFIX ULTRA ANCHOR GOT PULLED OUT DURING DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552355 ↗
• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR GOT PULLED OUT OF THE GUIDE HOLE WHEN THE SURGEON PULLED IT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE IN A NEW DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 17393303 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT DURING SET-UP FOR AN ACL, UPON OPENING A SUTUREFIX ULTRA, IT WAS NOTICED THAT IT WAS ALREADY BROKEN. THERE WAS NO DELAY NOR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200148 ↗
• InjuryMar 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A LATARJET STOP UNDER ARTHROSCOPY WITH BANKART, THE SUTUREFIX ANCHOR DID NOT HOLD AND BROKE DURING INSTALLATION. THE PROCEDURE WAS COMPLETED WITH ONE OF THE FAULTY DEVICES THAT WAS POSITIONED WITHOUT PROBLEM, THE BEAD WAS REPAIRED WITH 1 ANCHOR INSTEAD OF 2. THE REST OF THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY PULLING ON THE STRANDS, SINCE THE FAILURE WAS A DEFECT IN THE FIXATION OF THE ANCHOR DURING ITS RELEASE. THERE WAS A 30-MINUTE SURGICAL DELAY REPORTED. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516949 ↗