TWINFIX 72202067Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010619112), received between Jan 18, 2019 and May 26, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 other recall cover devices cleared under the same FDA submission (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING A SMALL JOINT ARTHROSCOPY, AFTER ONE (1) TWINFIX ANCHOR HAD BEEN PLACED AND THE TISSUES WERE BEING GATHERED FOR SUTURING, THE SUTURE FAILED, BREAKING WITHOUT ANY TRACTION APPLIED OR KNOT TYING PERFORMED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINS, USING A COMPETITOR DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280765 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF SMALL OPEN JOINTS PROCEDURE, DURING THE TISSUE SUTURING IN THE JOINT CAPSULE, IT WAS NOTICED ALL THE NEEDLES OF THE TWINFIX 2.8 ULTRABRAID CAME LOOSE FROM THE IMPLANT AFTER IT WAS PLACED. THE PROCEDURE WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, USING A VICRYL COMPETITOR DEVICE, USING THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408050 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREADS OF TWO (2) TWINFIX TI ANCHORS BROKE DURING IMPLANTATION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997271 ↗
• MalfunctionApr 23, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE TWINFIX 2.8 ULTRABRAID ANCHOR GOT BROKEN. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 21893014 ↗
• MalfunctionApr 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR 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 21839811 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWIN FIX ANCHOR FRACTURED INSIDE THE PATIENT, AND THE FRAGMENTS WERE REMOVED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE ANCHOR INSERTION, AND NO VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20838301 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A TEMPOROMANDIBULAR JOINT SURGERY, THE TWINFIX TI ANCHOR WAS FRACTURED INSIDE THE PATIENT. ALL THE PIECED WERE REMOVED FROM THE PATIENT USING TWEEZERS. 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 19314003 ↗
• InjuryApr 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A MAXILLOFACIAL INJURIES SURGERY, THE TWINFIX SCREW FRACTURED WHILE IMPLANTATION. THE FRACTURED PIECES WERE REMOVED FROM THE PATIENT. THE SURGERY WAS RESUMED, 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 16725609 ↗
• MalfunctionMar 1, 2023Break; Device Dislodged or Dislocated; Premature Separation; Break; Device Dislodged or Dislocated; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE THE SCREW OF THE TWINFIX 2.8 PULLED OUT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE AND IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461414 ↗
• InjuryFeb 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SPECIALIST WAS PLACING THE TWINFIX, HE PULLED THE ULTRABRAID STRANDS THAT COME OUT OF THE ANCHOR AND PULLED IT SO HARD THAT HE PULLED OUT THE ANCHOR COMPLETELY, A SECOND TWINFIX OF THE SAME LOT NUMBER WAS USED AND THE SAME THING HAPPENED BECAUSE IT IMPACTED THE ANCHOR TOO HARD AND PULLED THE STRANDS WITH ENOUGH FORCE. HE WAS INFORMED ABOUT THE PLACEMENT OF THE ANCHOR BUT HE IGNORED THE PROCEDURE AND ENDED UP DOING SOME STITCHES WITH THE SAME ULTRABRAID STRANDS OF THE ANCHORS. THERE WAS NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440966 ↗
• InjuryOct 6, 2022Break; Break

  IT WAS REPORTED THAT DURING A MAXILLOFACIAL REPAIR SURGERY, THE TWINFIX ANCHOR BROKE. ALL THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. A VOID WAS LEFT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15554251 ↗
• InjuryOct 6, 2022Break; Break

  IT WAS REPORTED THAT DURING A MAXILLOFACIAL REPAIR SURGERY, THE TWINFIX ANCHOR BROKE. ALL THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. A VOID WAS LEFT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15554068 ↗
• InjurySep 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS INTRODUCED WITHOUT PROBLEMS, BUT WHEN THE SUTURES WERE PASSED THROUGH THE TISSUES AND THE KNOTS WERE TIED, THEY BROKE WITHOUT MAKING A MAJOR EFFORT. THIS HAPPENED WITH THE TWO SUTURES, SO THE ANCHOR COULD NOT BE USED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379706 ↗
• InjurySep 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING MAXILLOFACIAL SURGERY, THE SCREW OF THE TWINFIX BROKE INSIDE OF THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (LESS OR EQUAL TO 30MIN), WITH A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550627 ↗
• InjuryJul 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A MAXILLOFACIAL SURGERY THE TWINFIX BROKE DURING USE. THE PIECE WAS RETRIEVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160892 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE HARPOON OF THE TWINFIX BROKE. THE PROCEDURE WAS COMPLETED CHANGING THE SURGICAL TECHNIQUE. IT IS UNKNOWN IF A DELAY OCCURRED. 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 11322434 ↗
• MalfunctionNov 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A WRIST CAPSULAR REPAIR, WHEN WE WERE PASSING THE POINTS THROUGH TISSUE, WHICH DID NOT RESIST, THE NEEDLE WAS DEFORMED UNTIL IT WAS ALMOST STRAIGHT. ADDITIONALLY, AT THE TIME OF THE KNOTTING, IT BURSTS, IT WAS VERIFIED IF IT WAS THE THREAD AND IT WAS EVIDENCED THAT IT WAS THE NEEDLE THAT BURST IN ITS PROXIMAL THIRD, LEAVING THE THREAD WITH A PIECE OF THE NEEDLE. HOWEVER, BY CONTINUING WITH THE KNOTTING, THE THREAD BURSTS 3 TIMES, EVEN WITHOUT BEING SUBJECTED TO HIGH TENSION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9336626 ↗
• MalfunctionJan 18, 2019Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING SURGERY, AFTER COMPLETING THE INSERTION OF THE SCREW, THEY STARTED TO PERFORM THE LIGAMENTORAPHY TO THE DELTOID TENDON. THEY STARTED TO SUTURE IN THE MIDDLE OF THIS PROCEDURE AND DOCTOR PASSED ONE OF THE NEEDLES THROUGH THE TENDON AND ITS EXTENSION. IN THE MIDDLE OF THIS MANEUVER, THEY OBSERVED THAT THE SUTURE WAS NOT PASSING COMPLETELY, IT WAS OBSERVED THAT THE NEEDLE APPARENTLY DISLODGED FROM THE SUTURE, SINCE IT DID NOT PASS IN ITS ENTIRETY AND THE GUIDE WAS ATTACHED TO THE TENDON, IT WAS POSSIBLE TO REMOVE THE NEEDLE WITH A KELLY CLAMPS. THEY CHECKED THE NEEDLE WITH ITS SUTURE AT IN DETAIL AND THE NEEDLE WAS BROKEN IN ITS PROXIMAL PART. IT IS UNKNOWN IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED BUT NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. THERE WAS NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262103 ↗

Recalls under the same FDA submission

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

• 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.