TWINFIX 72202602Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 03596010647573), received between May 13, 2018 and Mar 13, 2026 — classified as 22 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (40 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR, WHILE SCREWING IN ONE (1) TWINFIX ANCHOR, THE TIP BROKE. THE BROKEN ANCHOR WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING THE ANCHOR SHAFT ITSELF. 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 24598308 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE TWO (2) TWINFIX ANCHORS BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN 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 24433308 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHILE ATTEMPTING TO INSERT ONE (1) TWINFIX ANCHOR INTO THE PATIENT, THE ANCHOR BROKE. THE DAMAGED ANCHOR WAS SUCCESSFULLY REMOVED USING TWEEZERS. 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 23899725 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA ANCHOR BROKE INTO PIECES, IT WAS REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN AN ADDITIONAL BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS FINE.

  Patient problems: Perforation

  MAUDE report 22199817 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TWINFIX ULTRA ANCHOR FRACTURED WHEN TRIED TO BE IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749220 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TWINFIX ANCHOR WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514587 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TWINFIX ANCHOR WAS BROKEN. ALL THE PIECES WERE REMOVED WITH TWEEZERS AND SUCTION. 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 21510996 ↗
• MalfunctionDec 16, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE TWINFIX ANCHOR BROKE WHILE BEING IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20942472 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR OF THE TWINFIX ULTRA BROKE. THE ANCHOR WAS REMOVED. 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 20820706 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA BROKE WHILE INSERTING IN MEDIAL ROW. THE PROCEDURE WAS COMPLETED WITH A SURGICAL 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 20494875 ↗
• MalfunctionOct 2, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWINFIX ANCHOR WAS BENT AND DEFORMED, AND SOMETHING APPEARS TO BE BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, OR IF THERE WAS A DELAY. HOWEVER, IT WAS REPORTED THAT THERE WAS A BACKUP AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353242 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR SURGERY, THE TWINFIX ANCHOR BROKE WHILE THE IMPLANTATION. THE PIECES WERE REMOVED WITH TWEEZERS. 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 19080028 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR SURGERY, THE END OF THE SCREW OF THE TWINFIX ULTRA BROKE WHILE IMPLANTING IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL PIECES REMOVED USING TWEEZERS. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY BONE HOLE SO THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067360 ↗
• MalfunctionApr 8, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR SURGERY, HE TIP OF THE ANCHOR OF THE TWINFIX ULTRA BROKE WHILE IMPLANTING IT FOR 1/3. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL PIECES REMOVED USING TWEEZERS. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY BONE HOLE SO THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067044 ↗
• InjuryFeb 9, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CUFF RECONSTRUCTION AND A BICEPS TENODESIS, WHEN THE TWINFIX ULTRA 5.5MM ANCHOR WAS INSERTED, THE TWO WIRES CAME LOOSE AND THE ANCHOR REMAINED IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 18677201 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, DURING DEPLOYMENT, THE SCREW OF THE TWINFIX ULTRA GOT BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT 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 18607741 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT THE ANCHOR OF THE TWINFIX ULTRA BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418898 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA ANCHOR BROKE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE; HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418857 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA ANCHOR BROKE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE; HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418838 ↗
• MalfunctionNov 7, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING THE AVULSION FRACTURE OF THE POSTERIOR FORK INSERTION SURGERY, THE TWINFIX ULTRA ANCHOR BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 18085148 ↗
• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE COLLATERAL LIGAMENT REPAIR SURGERY, THE TWINFIX ULTRA SCREW BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765501 ↗
• MalfunctionJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TWINFIX ULTRA ANCHOR COULD NOT ENGAGE IN THE PILOT HOLE AND POPPED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153073 ↗
• InjuryApr 16, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AT THE TIME OF ENTERING THE TWINFIX ULTRA 5.5MM, IT FRACTURED. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748787 ↗
• InjuryApr 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE SCREWING THE TWINFIX ULTRA ANCHOR IN THE PILOT HOLE, THE ANCHOR GOT BROKEN. 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 16675175 ↗
• InjuryDec 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TWINFIX ULTRA ANCHOR GOT PULLED OUT OF THE CUFF. 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 15982942 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• Z-0167-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0159-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
• Z-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• Z-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0160-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• Z-0170-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992

…and 25 more.