TWINFIX 72202895Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 03596010652263), received between Sep 14, 2018 and Jun 16, 2026 — classified as 7 injuries, 28 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. 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING A PECTORAL MUSCLE REPAIR, ONE (1) TWINFIX ULTRA 5.5MM BROKE DURING PLACEMENT, AS ONLY THE SMOOTH INITIATOR WAS USED INSTEAD OF THE TRIFINE THREADER. THE BONE WAS VERY HARD, THE YOUNG PATIENT PEEKED AT THE WRENCH, AND THE ANCHOR BROKE AT THE WRENCH FITTING. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE, NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25525670 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE INSERTER OF THE TWINFIX WAS BROKEN DURING IMPLANTATION AND ALL THE COMPONENTS WERE REMOVED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THE BACK-UP DEVICE WAS INSERTED IN THE ORIGINAL HOLE. 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 21758965 ↗
• MalfunctionDec 19, 2024Break; Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, THE TWINFIX ANCHOR BROKE WHILE BEING INSERTED INTO THE BONE. THE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS 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 20978183 ↗
• MalfunctionDec 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY, WHEN THE ANCHOR OF THE TWINFIX ULTRA WAS BEING PLACED, IT BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS 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 20875388 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A BICEPS RUPTURE PROCEDURE, THE TWINFIX ULTRA 5.5MM ANCHOR BROKE INSIDE THE PATIENT'S BONE. IT WAS REMOVED WITH THE HELP OF PLIERS. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833282 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) TWINFIX ULTRA ANCHOR BODY DUSTED. THE ANCHORS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615506 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE PART THAT HOLDS THE TWINFIX ULTRA ANCHOR BROKE WHEN INSERTING THE ANCHOR INTO THE BONE. 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 19300096 ↗
• MalfunctionMay 3, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A SUTURE OF THE ROTATOR CUFF, TWO (2) TWINFIX ULTRA DEVICES FAILED. THE FIRST ANCHOR (B)(4) BROKE OFF THE SETTING TOOL AND WAS STUCK IN THE BONE, IT HAD TO BE REMOVED, IT WAS LOOSEN WITH A CLAMP AND CHISEL, IT WAS THEN SUCCESSFULLY UNSCREWED. THE SECOND ANCHOR (B)(4) WAS IMMEDIATELY BENT WHEN IT WAS SCREWED IN. SURGERY WAS COMPLETED WITH A CORKSCREW DEVICE FORM ARTHREX IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY OF 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241962 ↗
• MalfunctionMar 23, 2024Premature Activation; Detachment of Device or Device Component; Premature Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN INSERTED AND REMOVED THAT SHAFT, ONLY THE TIP OF THE TWIN FIX ULTRA ANCHOR REMAINED INSERTED, WHICH IS RELEASED BEFORE REMOVING THE SCREW. THE ANCHOR WAS REMOVED WITH KELLY CLAMPS. IT IS UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. THERE WAS A DELAY OF 8 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966046 ↗
• MalfunctionMar 22, 2024Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN THE THREADING WAS COMPLETED, THE TWINFIX ULTRA ANCHOR DISASSEMBLED FROM THE HANDLE AND INTERNAL SCREW. THE ANCHOR WAS ONLY ONE TURN AWAY FROM REACHING THE LASER LINE AND REMAINED FIXED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965129 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN THE TWINFIX ANCHOR WAS IMPACTED, IT BROKE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 10-MIN DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807598 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT, DURING A SUTURE OF THE ROTATOR CUFF, ONE TWINFIX ULTRA ANCHOR BROKE OFF THE SETTING TOOL AND WAS STUCK IN THE BONE, IT HAD TO BE REMOVED, IT WAS LOOSEN WITH A CLAMP AND CHISEL AND IT WAS SUCCESSFULLY UNSCREWED. SURGERY WAS COMPLETED WITH A CORKSCREW DEVICE FORM ARTHREX IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799755 ↗
• MalfunctionFeb 21, 2024Fracture; Unstable; Material Deformation; Fracture; Unstable; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CUFF SUTURE, THE ANCHOR OF THE TWINFIX ULTRA LOOSENED; NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW 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 18751852 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE INSERTION HANDLE OF THE TWINFIX ULTRA BROKE WHEN THE ANCHOR HIT THE BONE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 3 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 18686267 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TWINFIX ULTRA IMPACTED ONCE AGAINST THE HUMERAL HEAD WHEN THE SPECIALIST INTRODUCED THE DEVICE, AND BROKE IN ITS DISTAL PART. 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 18398696 ↗
• MalfunctionNov 16, 2023Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC CUFF SUTURE, THE TWINFIX ULTRA ANCHOR LOOSENED DURING IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE STATUS OF THE PATIENT IS VERY GOOD. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DISTAL END OF THE ANCHOR FRACTURED AWAY FROM THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18154618 ↗
• MalfunctionNov 16, 2023Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, SHORTLY BEFORE THE IMPLANTATION, IT WAS NOTICED THAT THE TWINFIX TITANIUM ANCHOR COULD NOT BE SCREWED IN AND WAS SITTING LOOSELY ON THE APPLICATOR. THE PROCEDURE WAS DELAYED FOR LESS THAN 30 MINUTES. BACK UP DEVICE WAS AVAILABLE. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE INSERTION DEVICE WAS RETURNED WITH THE DISTAL END FRACTURED AWAY FROM THE SHAFT. THE ANCHOR AND SUTURE STRINGS WERE STILL IN POSITION ON THE FRACTURED TIP OF THE INSERTER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18153757 ↗
• MalfunctionNov 15, 2023Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, SHORTLY BEFORE THE IMPLANTATION, IT WAS NOTICED THAT THE TWINFIX TITANIUM ANCHOR COULD NOT BE SCREWED IN AND WAS SITTING LOOSELY ON THE APPLICATOR. THE PROCEDURE WAS DELAYED FOR LESS THAN 30 MINUTES. BACK UP DEVICE WAS AVAILABLE. AS PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION SHOWS THE INSERTION DEVICE WAS RETURNED WITH THE DISTAL END FRACTURED AWAY FROM THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139426 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DISTAL PART OF THE TWINFIX ULTRA WAS BROKEN. 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 17953391 ↗
• MalfunctionOct 11, 2023Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWINFIX ANCHOR HANDLE CAME LOOSE WHEN THE SCREW WAS TIGHTENED. THE FIRST HOLE HAD NOT YET BEEN DRILLED BEFORE THE HANDLE BECAME LOOSE. 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 17916761 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A UNSPECIFIED PROCEDURE, THE TIP OF TWO(2) TWINFIX ANCHORS DETACHED INSIDE THE ARTICULATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17767923 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A UNSPECIFIED PROCEDURE, THE TIP OF A TWINFIX ANCHOR DETACHED INSIDE THE ARTICULATION. THE PROCEDURE WAS COMPLETED THE SAME DEVICE AND NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17767897 ↗
• InjuryMar 21, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE 'TWINFIX ULTRA, TI' ANCHOR WAS PLACED ON THE PRE-PREPARED BONE AND WHILE SCREWING IN (ANCHOR SUNK APPROX. HALFWAY) THE TIP OF THE SETTING INSTRUMENT CAME LOOSE, THUS THE ANCHOR COULD NOT BE SCREWED IN ANY FURTHER. THE INSERTER TIP SEPARATE FROM THE DEVICE CONSTRUCTION AND THE LOOSENED PIECE WAS RETRIEVED FROM THE ANATOMY. PATIENT BONE QUALITY WAS GOOD. IT IS UNKNOWN IF A VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841286 ↗
• InjuryFeb 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, TWO TWINFIX ULTRA SCREWS WERE FRACTURED DURING SCREWING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553079 ↗
• InjuryMar 26, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN ACL, THE TWINFIX ULTRA DID NOT FIT THE ROD WHICH MADE IT IMPOSSIBLE TO INSERT. AFTER A FEW ATTEMPTS IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 11575871 ↗