TWINFIX 72202595Recalls & reported problems

Summary

The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 03596010647467), received between Jul 24, 2017 and Jun 29, 2026 — classified as 188 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Break” (281 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 446 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE TWINFIX ULTRA BROKE WHILE IN USE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHO. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661982 ↗
• MalfunctionJun 29, 2026Break

  IT WAS REPORTED THAT, DURING ROTATOR CUFF REPAIR SURGERY, ONE (1) TWINFIX ANCHOR WAS BROKEN DURING THE IMPLANTATION. THE PROCEDURE WAS RESUMED WITH AN EQUIVALENT S+N BACK UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS REPORTED. NO SURGICAL REPORT IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648628 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE TWINFIX ULTRA ANCHOR BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT 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 25364160 ↗
• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE TWINFIX ULTRA ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN S+N EQUIVALENT BACK UP PRODUCT, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342088 ↗
• MalfunctionMay 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A RUPTURE OF THE SUPRASPINATUS TENDON ON THE RIGHT SHOULDER, WHEN PULLING THE SUTURE, THE HEAD TWINFIX ANCHOR CAME OFF AND SEPARATED FROM THE ANCHOR STEM, MAKING IT IMPOSSIBLE TO USE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE, NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 4.5 MM TAP AND THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT STATUS WAS FINE.NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089708 ↗
• MalfunctionApr 27, 2026Fracture; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR, THE TWINFIX ULTRA PK ANCHOR SLIPPED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001079 ↗
• MalfunctionApr 8, 2026Break; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER BOREHOLE PREPARATION USING THE 4.5 MM TOOL, ONE ANCHOR OF A (1) TWINFIX ULTRA COULD NOT BE INSTALLED AND DID NOT SELF-TAP PROPERLY. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. DURING INVESTIGATION IT WAS FOUND THAT ONE OF THE PRONGS AT THE DISTAL END OF THE INSERTION SHAFT IS BROKEN OFF, AND THE OTHER IS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817489 ↗
• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION SURGERY, THE TWINFIX ULTRA ANCHOR FRACTURED DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE, AND CLEARED FROM DEBRIS PRIOR TO INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539900 ↗
• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT DURING A KNEE MCL REPAIR, THE TWINFIX ULTRA ANCHOR WAS NOTED TO HAVE FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539891 ↗
• MalfunctionMar 3, 2026Fracture

  IT WAS REPORTED THAT DURING KNEE LCL REPAIR SURGERY, THE ANCHOR WAS NOTED TO HAVE FRACTURED DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498761 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT, DURING A LCL REPAIR PROCEDURE, THE TWINFIX ANCHOR WAS FRACTURED. 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 24484025 ↗
• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, ONE (1) TWINFIX ULTRA ANCHOR FRACTURED. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456059 ↗
• MalfunctionFeb 13, 2026Fracture

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE TWINFIX ANCHOR FRACTURED DURING THE IMPLANTATION. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332136 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, A TWINFIX ULTRA ANCHOR WAS BROKEN. 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 24324641 ↗
• MalfunctionFeb 3, 2026Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS BROKEN. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245142 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS BROKEN. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245124 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR BROKE. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239807 ↗
• MalfunctionFeb 2, 2026Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR BROKE. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239667 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE TWINFIX ULTRA ANCHOR BURST. THE PROCEDURE WAS RESUMED, WITHOUT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE; NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24230576 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS BROKEN. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220126 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS BROKEN. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220097 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS BROKEN. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199235 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, IT WAS NOTICED THAT THE TWINFIX ULTRA ANCHOR'S BODY HAD BROKEN BEFORE THE ANCHOR WAS FULLY EMBEDDED IN THE BONE SURFACE, AFTER BREAKING THROUGH THE CORTICAL BONE AND THEN, HAMMERED IN THE FRONT HALF OF THE ANCHOR. AFTER REMOVAL, IT WAS FOUND THAT THE IRON SHEET AT THE FRONT END OF THE INSERTER HAD ALSO BROKEN. LATER, IT WAS ALSO REMOVED WITH A FORCEPS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A JOHNSON & JOHNSON COMPETITOR DEVICE IN 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 24193026 ↗
• MalfunctionJan 14, 2026Unstable; Material Deformation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED WITH A 4.5 MM TAP AND CLEARED OF ALL DEBRIS, A TWINFIX ULTRA ANCHOR WAS NOT FIXED TIGHTLY. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067798 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR, THE TWINFIX ULTRA PK BROKE. THE PIECE WERE REMOVED FROM INSIDE THE PATIENT USING FORCEPS. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989047 ↗