TWINFIX 72202897Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 03596010652317), received between Jun 20, 2019 and Feb 11, 2026 — classified as 5 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY, THE SCREWDRIVER BROKE WHILE SCREWING IN ONE (1) TWINFIX ANCHOR, IT REMAINED SCREWED IN HALFWAY AND IT WAS DIFFICULT TO EXTRACT IT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A 40-MINUTE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313516 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE DISTAL PART OF TWO (2) TWINFIX ULTRA SCREWDRIVERS CAME OFF FROM THE HANDLE WHILE TRYING TO SCREW IN THE ANCHORS. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW 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 19945356 ↗
• MalfunctionJul 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE TWINFIX ULTRA BROKE INTO PIECES THERE WAS A BACK UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861115 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, DURING THE INSERTION OF THE TWINFIX ULTRA, THE TERMINAL PART OF THE STEM BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818299 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE SCREW HOLDER OF THE TWINFIX ULTRA BROKE. NO SURGICAL DELAY WAS REPORTED; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655970 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SCREW OF THE TWINFIX THAT WAS IN CONTACT WITH THE BONE SNAPPED OFF THE SCREWDRIVER WITHOUT BEING ABLE TO BE SCREWED IN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A COMPETITOR BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600812 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWINFIX ULTRA ANCHOR TIP BROKE WHEN IT WAS INSERTED, IT BROKE AT THE TIME OF ROTATION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554839 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE END PART OF THE IMPLANT HOLDER BROKE WHILE SCREWING THE TWINFIX ANCHOR. 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 19454795 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE ATTEMPTING TO SCREW THE ANCHOR OF THE TWINFIX ULTRA, THE SCREWDRIVER IN THE DISTAL PART DETACHED, RENDERING THE ANCHOR UNUSABLE (COULD NO LONGER BE SCREWED). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454195 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TWINFIX ULTRA SUTURE ANCHOR FAILED, DURING THE ATTEMPT TO SCREW THE ANCHOR, THE DISTAL PART OF THE SCREWDRIVER THAT HOLDS THE SCREW FIXED CAME OFF, MAKING THE PRODUCT NO LONGER USABLE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372560 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TWINFIX ULTRA SUTURE ANCHOR FAILED, DURING THE ATTEMPT TO SCREW THE ANCHOR, THE DISTAL PART OF THE SCREWDRIVER THAT HOLDS THE SCREW FIXED CAME OFF, MAKING THE PRODUCT NO LONGER USABLE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354447 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DISTAL AREA OF THE TWINFIX ULTRA SCREWDRIVER DETACHED FROM THE STEM, PREVENTING SCREWING AND THEREFORE MAKING THE PRODUCT UNUSABLE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324221 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TERMINAL PART OF TWO (2) TWINFIX ULTRA IMPLANT HOLDERS BROKE WHILE SCREWING THE ANCHOR. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319920 ↗
• MalfunctionMar 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PART OF THE TWINFIX ANCHOR WHERE THE WIRES RUN HAS DISENGAGED FROM THE BODY OF THE ANCHOR ITSELF, THUS BECOMING UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942204 ↗
• MalfunctionMar 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE TWINFIX ULTRA TI ANCHOR DID NOT HOLD ON TO THE BONE AND IT CAME OUT OF THE CORTEX. THE PROCEDURE WAS COMPLETED WITH A S+N 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 18898040 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INNER PART OF THE TWINFIX ANCHOR WAS STUCK AND DID NOT COME OFF WHEN THE HANDPIECE WAS PULLED OUT. THE ANCHOR WAS REMOVED WITH THE HELP OF ANOTHER FORCEPS. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE HOLE WAS NOT DRILLED IN ADVANCE AND EVERYTHING WAS CARRIED OUT AS USUAL. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395263 ↗
• InjuryJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE IMPLANT OF THE TWINFIX ULTRA COULDN'T HOLD IN THE PILOT HOLE AND POPPED OUT. THE SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158809 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, A TWINFIX ULTRA´S SUTURE BROKE OFF. SURGERY RESUMED AFTER NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936322 ↗
• InjuryMay 8, 2021Expulsion; Expulsion

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, AFTER DEPLOYING THE "5.5MM TWINFIX SUTURE ANCHOR", THE ANCHOR PULLED OUT OF THE BONE WHILE TENSIONING IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795354 ↗
• MalfunctionMay 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER DEPLOYING THE ANCHOR, WHILE TENSIONING, THE ANCHOR PULLED OUT OF THE BONE HOLE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795326 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING A TWINFIX ULTRA, THE INSERTER BROKE WHEN ENTERING THE BONE. THE PIECES WERE RETRIEVED WITH TWEEZERS. THE ORIGINAL BONE HOLE WAS EXPANDED TO USE THE BACKUP. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTES OR LESS DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. 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 11580063 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING A TWINFIX ULTRA, THE INSERTER BROKE WHEN ENTERING THE BONE. THE PIECES WERE RETRIEVED WITH TWEEZERS. THE ORIGINAL BONE HOLE WAS EXPANDED TO USE THE BACKUP. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTES OR LESS DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. 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 11580062 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING A TWINFIX ULTRA, THE INSERTER BROKE WHEN ENTERING THE BONE. THE PIECES WERE RETRIEVED WITH TWEEZERS. THE ORIGINAL BONE HOLE WAS EXPANDED TO USE THE BACKUP. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTES OR LESS DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. 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 11580060 ↗
• MalfunctionMar 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING A TWINFIX ULTRA, THE INSERTER BROKE WHEN ENTERING THE BONE. THE PIECES WERE RETRIEVED WITH TWEEZERS. THE ORIGINAL BONE HOLE WAS EXPANDED TO USE THE BACKUP. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTES OR LESS DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. 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 11580059 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, AS SOON AS THE SURGEON STARTED TO SCREW THE TWINFIX ULTRA ON THE PATIENT'S BONE, THE STEM THAT SUPPORTS THE SCREW WAS DISTALLY BROKEN. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT WITH SUCTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS. 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 11420499 ↗