TWINFIX 72202599Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 03596010647474), received between Jun 11, 2018 and Nov 7, 2025 — classified as 23 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWINFIX ULTRA ANCHOR WAS INSERTED INTO THE BONE CHANNEL, DURING THE ROTATION AND INSERTION PROCESS, THE ANCHOR BROKE, THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SN EQUIVALENT DEVICE IN AN ADDITIONAL BONE HOLE, THERE WAS A VOID LEFT IN PATIENT, WITH NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23500479 ↗
• MalfunctionJun 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SURGERY, THE HEAD OF A TWINFIX ULTRA ANCHOR WAS DISCONNECTED, WHILE IMPLANTING IT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121242 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE TWINFIX ULTRA PK ANCHOR BROKE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21925961 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT DURING USE THE SCREW OF THE TWINFIX ULTRA WAS FRACTURED. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072770 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ELBOW JOINT SURGERY, THE ANCHOR OF TWO (2) TWINFIX ULTRA BROKE WHEN SCREWED IN THE INSERTION SITE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819589 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE SCREW WAS TWIST IN, THE TWINFIX ULTRA ANCHOR'S HEAD BROKE BECAUSE THE CORTICAL WAS TOO HARD AND THE DIRECTION WAS CHANGED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 19165697 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SHOULDER CUFF REPAIR SURGERY, DURING IMPLANTATION, THE FRONT END OF THE TWINFIX ULTRA ANCHOR CRACKED BUT NO PIECES WERE DETACHED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT AND THE SITE WAS CLEARED PRIOR TO THE INSERTION OF THE ANCHOR. THERE WAS LESS THAN 30 MINUTE SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18732281 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT PATELLA FRACTURE INCISION AND REDUCTION INTERNAL FIXATION, USING A TWINFIX ULTRA DEVICE, THE PATIENT WAS FOUND TO HAVE ULCERATION AT THE DISTANT END OF THE WOUND WHICH WAS DIAGNOSED AS INTERNAL FIXATION REJECTION. THEREFORE, AN INCISION WAS MADE TO REMOVE THE INTERNAL FIXATION, AND POSTOPERATIVE ANTI-INFLAMMATORY DRUGS WERE APPLIED, AND THE WOUND HEALED WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Ulcer

  MAUDE report 18267487 ↗
• MalfunctionOct 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER DISLOCATION SURGERY, TWINFIX ULTRA SCREW BROKE WHILE IT WAS BEING SCREW. 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 17959055 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WRONG AWL WAS EMPLOYED TO CREATE ACCESS IN THE BONE. THEREFORE, WHEN THE TWINFIX ULTRA ANCHOR WAS TAPPED, IT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927255 ↗
• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA BROKE AND IT WAS ENTIRELY REMOVED BY THE SURGEON. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17768544 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER CUFF REPAIR SURGERY, THE TWINFIX SCREW BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665953 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER CUFF REPAIR SURGERY, THE TWINFIX SCREW BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665929 ↗
• MalfunctionAug 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ARTHROSCOPY THE TWINFIX ULTRA ANCHOR CAME OUT AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT 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 17634476 ↗
• MalfunctionJul 31, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED WITH SUCTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430556 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR TWINFIX ULTRA BROKE WHILE IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT 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 17031601 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE TWINFIX ULTRA ANCHOR WAS BEING SCREWED IN THE BONE, THE TIP OF THE ANCHOR BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE DRILLED HOLE BY GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906854 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT SUTURE SURGERY, THE TWINFIX ULTRA SUTURE ANCHOR BROKE OUTSIDE THE PATIENT AND FELL OFF. THE PROCEDURE WAS COMPLETED WITH A NON-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 16725706 ↗
• InjuryMar 31, 2023Break; Break

  IT WAS REPORTED THAT, DURING A KNEE COLLATERAL LIGAMENT REPAIR SURGERY, THE TWINFIX ULTRA SCREW BROKE WHILE IT WAS SCREWING. 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 16656784 ↗
• MalfunctionMar 3, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN OPENING THE PACKAGING, THE TWINFIX ULTRA DEVICE WAS EXPOSED AND NOT IN A STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478306 ↗
• InjuryFeb 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE TWINFIX ULTRA SCREW BROKE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444349 ↗
• InjuryFeb 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE TAPING INSIDE THE CUFF, THE TWINFIX IMPLANT CAME OUT. 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; Rupture

  MAUDE report 16405190 ↗
• InjuryNov 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF TEAR REFIXATION, THE 5.5MM TWINFIX ANCHOR BROKE DURING DEPLOYMENT. THE BROKEN PART STAYED ON THE SHAFT. THE PROCEDURE WAS COMPLETED WITH A 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 15807184 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE TWINFIX GOT BROKEN WHILE DEPLOYING. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN THE ORIGINAL BONE HOLE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. NO VOID WAS LEFT IN THE PATIENT. INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A GRASPER STANDARD. THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. PATIENT CURRENT STATUS IS NORMAL. THE SURGEON WAS ULTIMATELY SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584171 ↗
• InjuryJul 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, TWO (2) TWINFIX ULTRA ANCHORS BROKE WHILE DEPLOYING. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE IN THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061830 ↗