TWINFIX 72200752Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 03596010578921), received between Aug 17, 2017 and Mar 30, 2026 — classified as 21 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANKLE JOINT LIGAMENT REPAIR SURGERY, THERE WAS MATERIAL FRAGMENTATION AT THE HEAD OF ONE (1) TWINFIX ANCHOR. ALL THE FRAGMENTS WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724077 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, IT WAS NOTICED THAT A TWINFIX ANCHOR AND THE SUTURE WERE BROKEN. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23253923 ↗
• MalfunctionOct 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN MPFL PROCEDURE, TWO (2) TWINFIX DEVICES HAD VERY STIFF SUTURES, AND THE SURGEON SAID IT WAS VERY HARD TO TIE KNOTS. SURGEON WAS NOT ABLE TO GET THE DESIRED OUTCOME DUE TO THE STIFF SUTURES, SO THE ANCHORS WERE REMOVED. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A COMPETITOR DEVICE (ARTHREX SWIVELOCK). THE BACK UP DEVICE WAS USED IN THE SAME BONE HOLES, HOWEVER THE SURGEON HAD TO REDRILL THE HOLES WITH A LARGER DRILL TO ACCOMMODATE THE NEW ANCHORS. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 23219015 ↗
• MalfunctionJun 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, WHEN THE TWINFIX TI 3.5 ULTRABRAID WAS BEING SCREWED INTO THE BONE, THE SUTURE BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE INSERTION WAS SITE CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USED IN THE SAME ORIGINALLY DRILLED BONE HOLE. 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 22303899 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TENDON REPAIR SURGERY, THE TWINFIX DISTAL END OF THE SHAFT WAS BROKEN WHEN IT WAS BEING INSERTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USED IN THE ORIGINALLY DRILLED BONE HOLE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. 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 20726927 ↗
• InjuryNov 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TWINFIX SUTURE IN THE PATIENT'S BODY BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20710212 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ACL AND LEMAIRE PROCEDURE USING A TWINFIX ANCHOR, THE PATIENT HAD A STAPHYLOCOCCUS CAPRAE INFECTION. THE PATIENT'S KNEE WAS RINSED OUT WITH ANTIBIOTIC SOLUTION AND THE IMPLANT REMAINED IN THE PATIENT. 2 X OPENING + RE-OPERATION WITH ARTHROSCOPIC FLUSHING WAS REQUIRED. THE INFECTION WAS CONTROLLED WITH ARTHROSCOPIC RINSING AND ANTIBIOTIC TREATMENT (LEVOFLOXACIN + RIFAMPICIN). THE KNEE IS STABLE WITH PRESERVATION OF ACL RECONSTRUCTION EXPECTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: Bacterial Infection

  MAUDE report 20344283 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF SURGERY, THE TWINFIX SCREW BROKE OFF AND WAS SLIPPING, THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166578 ↗
• MalfunctionApr 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, TWINFIX 3.5 TI ANCHOR DID NOT HOLD ONTO THE BONE AND 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 19032230 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN 2020 A PATIENT HAD AN AVULSION FRACTURE OF THE INFERIOR STOP OF THE ACL OF THE RIGHT KNEE, WHICH WAS TREATED WITH MICROSCOPIC REDUCTION AND INTERNAL FIXATION USING A TWINFIX. ON (B)(6) 2023 THE PATIENT PRESENTED WITH AN ARTICULAR STRANGULATION AND WAS ADMITTED TO THE HOSPITAL FOR THE REMOVAL OF THE INTERNAL FIXATION. COMBINED ANTIBIOTICS WERE USED. PATIENT RECOVERED WELL AND WAS DISCHARGED FROM THE HOSPITAL WITH GOOD HEALING.

  Patient problems: Cartilage damage; Insufficient Information

  MAUDE report 18145013 ↗
• MalfunctionSep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY THE TWINFIX´S SUTURE FELL OFF AFTER THE ANCHOR WAS IMPLANTED IN THE PATIENT, THE ANCHOR WAS REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED IMPLANTING A S+N BACK UP DEVICE IN THE SAME BONE HOLE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843944 ↗
• InjuryFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A PATELLA DISLOCATION REPAIR PROCEDURE, THE TWINFIX SCREW BROKE FROM THE RIB. IT IS UNKNOWN IF IT OCCURRED INSIDE OR OUTSIDE OF THE PATIENT. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456983 ↗
• InjuryNov 21, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER JOINT SURGERY, THE INSERTER BIOSURE BROKE. THE SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. THE PATIENT CURRENT STATUS IS GOOD, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832542 ↗
• InjuryNov 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL, AFTER IMPACTING A TWINFIX ULTRABRAID ANCHOR IN THE BONE AND FIXING THE ANCHOR, AS WELL AS THE RESISTANCE OF THE BONE; THE ANCHOR BROKE, AND WAS REMOVED USING A PAIR OF PLIER. SURGERY RESUMED WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT´S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813171 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AFTER AN ELBOW JOINT PROCEDURE WITH A TWINFIX ULTRABRAID, THE INCISION WAS INFECTED WITH PURULENT DISCHARGE, WHICH WAS TREATED WITH DEBRIDEMENT, BACTERIAL CULTURE, BONE CEMENT FILLING AND ANTIBIOTICS. THE SYMPTOMS WERE RELIEVED. THE CURRENT STATUS OF THE PATIENT IS FINE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15812680 ↗
• InjuryNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A PATELLOFEMORAL LIGAMENT RECONSTRUCTION, THE SCREW OF THE TWINFIX ULTRABRAID FELL OFF THE PATIENT. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN AN ADDITIONAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15796378 ↗
• InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING USE, THE TWINFIX ANCHOR FELL OFF THE SUTURE WHEN KNOTTING. SURGERY WAS RESUMED, USING A BACK-UP DEVICE INSTEAD, HOWEVER, IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15363832 ↗
• InjuryFeb 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ANKLE LIGAMENT REPAIR, THE ANCHOR OF THE TWINFIX ULTRABRAID WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547014 ↗
• InjuryDec 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR SURGERY, THE SUTURE OF THE TWINFIX TITANIUM 3.5 ULTRABRAID WAS BREAKING UP. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120183 ↗
• InjuryNov 1, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, DURING SHOULDER CUFF REPAIR SURGERY, THE SCREW OF THE TWINFIX BACKED OFF AFTER IMPLANTATION. THE ANCHOR WAS REMOVED FROM THE PATIENT USING TWEEZERS. PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733623 ↗
• InjuryAug 27, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE, THE ANCHOR OF THE TWINFIX FRACTURED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379895 ↗
• InjuryAug 25, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER DISLOCATION SURGERY, THE SUTURE OF TWINFIX FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365172 ↗
• InjuryJun 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE ANCHOR OF THE TWINFIX SLIDE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN AN ADDITIONAL BONE HOLE. NO DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029101 ↗
• InjuryJun 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING BANKART REPAIR, INSIDE THE PATIENT, THE TWINFIX TI 3.5 ULTRABRAID GOT DISLODGED FROM THE BONE TUNNEL. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959769 ↗
• InjuryApr 6, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A LATERAL COLLATERAL LIGAMENT SURGERY, USING THE TWINFIX TI 3.5 ULTRABRAID, THE ANCHOR COULD NOT BE IMPLANTED AFTER SCREW-IN FOR 2/3. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IN THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618777 ↗

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.