TWINFIX 72202603Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010647597), received between Sep 4, 2017 and Mar 9, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE ANCHOR BROKE WHILE BEING INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT 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 9809270 ↗
• MalfunctionFeb 15, 2018Break

  IT WAS REPORTED THAT THE ANCHOR SCREW BROKE DURING INSERTION INSIDE THE PATIENT. PIECES WERE REMOVED. THE PROCEDUE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7275377 ↗
• MalfunctionFeb 15, 2018Break

  IT WAS REPORTED THAT THE ANCHOR SCREW BROKE DURING INSERTION INSIDE THE PATIENT. PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7275355 ↗
• MalfunctionFeb 14, 2018Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR SCREW BROKE DURING INSERTION INSIDE THE PATIENT. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7270206 ↗
• MalfunctionSep 13, 2017Break

  IT WAS REPORTED THAT THE TWINFIX TIP WAS BROKEN INSIDE THE PATIENT, HOWEVER ALL THE PIECES WERE REMOVED. NO ADDITIONAL HOLES WERE MADE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861308 ↗
• MalfunctionSep 13, 2017Break

  IT WAS REPORTED THAT THE TWINFIX TIP WAS BROKEN. THE TIP BROKE INSIDE THE PATIENT, HOWEVER ALL THE PIECES WERE REMOVED. NO ADDITIONAL HOLES WERE MADE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861299 ↗
• MalfunctionSep 4, 2017Break

  IT WAS REPORTED ANCHOR BROKE WHILE INSERTING ON HUMERAL HEAD. BROKEN ANCHOR WAS REMOVED FROM THE PATIENT. NO PROCEDURE DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841023 ↗

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-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• 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-0168-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
• 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-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0164-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
• Z-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• Z-0143-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
• 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-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610

…and 25 more.