TWINFIX 72202626Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010647580), received between Sep 14, 2018 and Aug 20, 2025 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE TWINFIX ULTRA HA ANCHOR BROKE WHILE IT WAS BEING PUT INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851359 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA ANCHOR BROKE WHILE BEING SCREWED INTO THE BONE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912964 ↗
• MalfunctionJun 25, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ANCHOR OF THE TWINFIX ULTRA GOT BROKEN WHILE BEING DEPLOYED. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196146 ↗
• InjuryDec 25, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TWINFIX ANCHOR GOT BROKEN WHILE INTO THE HUMERUS BONE, ALL BROKEN PIECES WERE REMOVED SUCCESSFULLY USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY 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 16046045 ↗
• InjuryDec 6, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHERE A GOLDEN AWL WAS USED TO PREPARE THE INSERTION SITE, TWO (2) TWINFIX ULTRA ANCHORS GOT BROKEN WHILE BEING INSERTED INTO THE BONE, EVENT AFTER PROPER PROCEDURE WAS FOLLOWED BY THE SURGEON. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, EASILY USING FORCEPS. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE IN AN ADDITIONAL DRILLED BONE HOLE, HOWEVER NO VOIDS WERE LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15929258 ↗
• InjuryNov 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE IMPLANT OF THE TWINFIX ULTRA SUTURE ANCHOR BROKE DURING THE DEPLOYMENT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED WITH THE HELP OF FORCEPS. 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 15760200 ↗
• InjuryNov 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE IMPLANT OF THE TWINFIX ULTRA SUTURE ANCHOR BROKE WHEN DEPLOYED. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED WITH HELP OF FORCEPS. 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 15755431 ↗
• InjuryJul 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE TWINFIX ULTRA SUTURE ANCHOR BROKE WHILE INSERTING IT INTO THE BONE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14891426 ↗
• InjuryMay 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE TIP OF THE TWINFIX ANCHOR GOT BROKEN DURING THE DEPLOYMENT INTO THE BONE, THE BROKEN PIECES WERE REMOVED FROM THE BONE USING GRASPER. THIS RESULTED IN A NON-SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491306 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ANCHOR BROKE WHILE SCREWING IN. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IMPLANTED IN AN ADDITIONAL BONE HOLE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING GRASPERS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13702932 ↗
• InjuryJan 21, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE TWINFIX ULTRA BROKE DURING DEPLOYMENT. ALL THE BROKEN PIECES WERE REMOVED FROM THE BONE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE IN A NEW BONE HOLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture; Unspecified Tissue Injury

  MAUDE report 13315074 ↗
• InjuryNov 10, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE TWINFIX ANCHOR TIP BROKE WHILE INSERTING INTO THE BONE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NON-SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788632 ↗
• MalfunctionOct 20, 2020Crack; Crack

  IT WAS REPORTED THAT THE ANCHOR WAS CRACKED DURING AN UNKNOWN PROCEDURE. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10704666 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE ANCHOR BROKE WHILE INSERTING. THE PIECES WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT 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 9777948 ↗
• MalfunctionNov 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE ANCHOR BROKE WHEN IT WAS BEING INSERTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 9390473 ↗
• MalfunctionSep 14, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DESPITE USING TAP. THE ANCHOR WAS COMPLETELY REMOVED FROM PATIENT AND AN ADDITIONAL HOLE WAS NOT NEEDED TO FINISH THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7879097 ↗

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-0141-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• Z-0169-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• Z-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• Z-0171-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0172-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
• Z-0173-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0143-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

…and 25 more.