TWINFIX 72200750Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 03596010584472), received between May 2, 2017 and Jun 29, 2026 — classified as 14 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

2 other recalls cover devices cleared under the same FDA submission (K152566, K972326); they may or may not involve this specific model.

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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN INSTABILITY PROCEDURE, WHILE TYING THE SUTURE OF ONE (1) TWINFIX ANCHOR, THE SUTURE MATERIAL GOT DAMAGED. 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 25658867 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING A BANKART PROCEDURE, THE TWINFIX TI 2.8 ULTRABRAID'S THREAD GOT BROKEN, IT GOT CUT OFF. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238007 ↗
• MalfunctionFeb 20, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DR. ATTEMPTED TO INSERT ONE (1) TWINFIX ANCHOR FOR A CAPSULORRHAPHY. THE PATIENT'S DISLOCATION INJURY PREVENTED THE PROPER ENTRY POINT FOR THE ANCHOR, AND WHEN ATTEMPTING TO PLACE THE ANCHOR, THE TIP BENT; PREVENTING ITS INSERTION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE, IT WAS NECESSARY TO DRILL A LITTLE DEEPER. NO VOID LEFT. THE PATIENT'S STATUS IS STABLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24401212 ↗
• MalfunctionNov 3, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING A TEMPOROMANDIBULAR JOINT ANCHOR FIXATION SURGERY, IT WAS NOTICED THAT THE TWINFIX TI ULTRABRAID BROKE. THE BROKEN FRAGMENTS WERE REMOVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459827 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IT WAS NOT POSSIBLE TO PLACE THE TWINFIX IMPLANT DUE TO A THREAD BREAKAGE. 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 22328911 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE TWINFIX THREAD GOT BROKEN AT THE TIME OF TIGHTENING THE KNOT. 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 22254078 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE OF THE TWINFIX BROKE. 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 21542877 ↗
• MalfunctionMar 3, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE THE TWINFIX ANCHOR COULD NOT BE SEPARATED FROM THE DEVICE. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE , THERE WAS A DELAY OF LESS THAN 30 MINUTES. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21510848 ↗
• MalfunctionFeb 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREAD ON THE TWINFIX ULTRABRAID ANCHOR GOT CUT. 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 21463352 ↗
• MalfunctionMar 28, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING AN ACL, WHEN INSTALLING A TWINFIX ULTRABRAID, THE PRE-INSTALLED THREADS WITHIN REMAINED IN THE INSERTER; AS A RESULT THE FIXATOR REMAINED IN THE BONE, WHILE THE THREADS WERE LEFT BEHIND IN THE HANDLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997587 ↗
• MalfunctionMar 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ANCHOR COULDN'T HOLD IN THE PILOT HOLE AND POPPED OUT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887827 ↗
• InjuryMar 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX EYE OF THE ANCHOR BROKE OFF DURING IMPLANTATION. A BROKEN PIECE OF THE ANCHOR WITH THE EYE AND THREADS REMAINED IN THE INSERTER; HOWEVER, A FRAGMENT COULD NOT BE EXTRACTED AND WAS LEFT SECURED IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE NEAR THE ORIGINAL DRILLED BONE HOLE; A VOID WAS LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 18847243 ↗
• InjuryJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL, AFTER A TWINFIX WAS IMPLANTED INTO THE BONE AND THE SURGEON PULLED THE SHAFT OUT OF THE BODY, THE SUTURE OF THE TWINFIX CAME OFF. THE ANCHOR REMAINED IN THE BONE. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF 5 MINUTES WITH A BACK-UP DEVICE USED IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 18520241 ↗
• InjurySep 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREAD OF THE TWINFIX SUTURE BROKE WHEN THE SURGEON WAS TYING THE KNOT. THE ANCHOR REMAINED INSIDE THE PATIENT'S BONE AND AN ADDITIONAL BONE HOLE WAS DRILLED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 17805208 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE TRAUMA SURGERY, THE TWINFIX ANCHOR BROKE. 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 17775546 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A RIGHT SHOULDER JOINT ARTHROSCOPY AND BANKART REPAIR WERE PERFORMED TO TREAT THE PATIENT'S RECURRENT RIGHT SHOULDER DISLOCATIONS. A TOTAL OF THREE TITANIUM (3) TWINFIX ULTRABRAID SUTURE ANCHORS WERE USED. THE PATIENT WAS DISCHARGED ON (B)(6) 2021, BUT ONE MONTH AFTER SURGERY, ITCHY HIVES STARTED TO APPEAR THROUGHOUT THE PATIENT'S BODY, AND SPREAD TO THE LIMBS, WITH ITCHING AND SWELLING OF THE LIPS. THE PATIENT SELF-KEPT TO A HYPOALLERGENIC DIET WITHOUT ANY EFFECT. THE PATIENT TOOK AG (ZYRTEC, CETIRIZINE) ONCE EVERY 2 DAYS WITH MODERATE EFFECT, AND LINEAR URTICARIA (DERMOGRAPHISM) BEGAN TO APPEAR. THE PATIENT WAS DIAGNOSED WITH CHRONIC SPONTANEOUS URTICARIA (TITANIUM FASTENERS) AND RECURRENT ANGIOEDEMA. IT IS UNKNOWN WHAT REMEDIAL ACTIONS WERE TAKEN AND THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16864593 ↗
• MalfunctionApr 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE THREADS OF THE TWINFIX HAD BEEN CUT. 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 16755843 ↗
• MalfunctionApr 13, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO 2 TWINFIX ANCHORS HAD THE SAME MALFUNCTION. THE SHAFTS OF EACH DEVICE WERE NOT ENGRAVED WITH THE USUAL TWO LASER MARKS OF BLACK COLOR. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733025 ↗
• InjuryApr 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING A LATERAL COLLATERAL LIGAMENT REPAIR SURGERY, THE TWINFIX SCREW CRACKED. THE PIECES WERE REMOVED FROM THE PATIENT. THE SURGERY WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725551 ↗
• InjuryJul 5, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ANKLE LIGAMENT REPAIR SURGERY, THE TWINFIX SCREW BROKE INTO PIECES WHILE BEING SCREWED IN AND, THE SUTURE GOT STUCK IN THE INSERTER. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917306 ↗
• InjuryMar 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, WHEN THE TWINFIX ANCHOR WAS INSERTED INTO THE BONE HOLE, THE ANCHOR BROKE FROM THE HEAD PART. THE BROKEN PIECES OF THE HEAD PART WEREN'T REMOVED FROM THE PATIENT. AS PART OF THIS PRODUCT WAS LEFT IN THE PATIENT, THE PROCEDURE WAS CANCELLED DUE TO THERE WAS NO SPACE TO IMPLANT FOR A BACK-UP DEVICE. THIS FAILED ANCHOR WAS THE SECOND ONE, THERE WAS AN ANCHOR IMPLANTED ALREADY DURING THE PROCEDURE, SO THE DOCTOR DECIDED NOT TO GO ON THE PROCEDURE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13896524 ↗
• InjuryFeb 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE, THE 'TWINFIX' ANCHOR PULLED OUT POST DEPLOYMENT. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13537037 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ROTATOR CUFF REPAIR, INSIDE THE PATIENT, THE SUTURE OF THE TWINFIX TI 2.8 ULTRABRAID WAS BROKEN. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT 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 11690903 ↗
• InjuryMar 15, 2021Break; Break

  IT WAS REPORTED THAT DURING A REPAIR OF SHOULDER INSTABILITY, THE SUTURE IN THE TWINFIX TI 2.8 ULTRABRAID BROKE AFTER THE ANCHOR WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. NO PATIENT 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 11489872 ↗
• InjuryDec 29, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE ANCHOR WAS BEING INTRODUCED, THERE WAS RESISTANCE IN THE BONE AND THE ANCHOR LOOSE HANDLE AND CANNOT BE FURTHER INTRODUCED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE IMPACTING IT ON THE SAME BONE HOLE. THERE WAS NO DELAY OR FURTHER COMPLICATIONS 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 11091619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152566, K972326. One submission often covers many models, so check the product and lot details in each record.

• Z-0581-2025 · Oct 29, 2024 · Open, Classified
  BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.