TWINFIX 72202900Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010652324), received between May 28, 2019 and Oct 16, 2023 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, TWO (2) TWINFIX ULTRA INSERTERS BROKE WHEN SCREWING-IN THE ANCHORS. THE BROKEN PIECES WERE REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NON SIGNIFICANT SURGICAL DELAY. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 17941681 ↗
• InjuryMar 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TWINFIX ANCHOR BROKE DURING USAGE. 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 16616751 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "COMPARISON OF SINGLE VERSUS DOUBLE-ROW TECHNIQUES IN ARTHROSCOPIC ROTATOR CUFF REPAIR OF FULL-THICKNESS TEARS", 4 PATIENTS HAD A RE-TEAR AFTER A DOUBLE ROW ROTATOR CUFF REPAIR PROCEDURE USING A FOOTPRINT PK ANCHOR. THIS EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 12917442 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "ARTHROSCOPIC BANKART REPAIR WITH REMPLISSAGE FOR NON-ENGAGING HILL-SACHS LESION IN PROFESSIONAL COLLISION ATHLETES", ONE PATIENT HAD A UNSTABLE SHOULDER DUE TO A NEW SUBLUXATION AFTER A ARTHROSCOPIC BANKART REPAIR PROCEDURE USING A KINSA SUTURE ANCHOR. THIS EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY. THE PATIENT HAD A STABLE SHOULDER WITH NO APPREHENSION AT FINAL FOLLOW-UP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Subluxation

  MAUDE report 12917415 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "ARTHROSCOPIC BANKART REPAIR WITH REMPLISSAGE FOR NON-ENGAGING HILL-SACHS LESION IN PROFESSIONAL COLLISION ATHLETES", FIVE PATIENTS HAD A UNSTABLE SHOULDER DUE TO A NEW DISLOCATION AFTER A ARTHROSCOPIC BANKART REPAIR PROCEDURE USING A KINSA SUTURE ANCHOR. THIS EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY. THE PATIENT HAD A STABLE SHOULDER WITH NO APPREHENSION AT FINAL FOLLOW-UP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 12917273 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "COMPARISON OF SINGLE VERSUS DOUBLE-ROW TECHNIQUES IN ARTHROSCOPIC ROTATOR CUFF REPAIR OF FULL-THICKNESS TEARS", 4 PATIENTS HAD A RE-TEAR AFTER A SINGLE ROW ROTATOR CUFF REPAIR PROCEDURE USING A TWINFIX ANCHOR. THIS EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 12917214 ↗
• MalfunctionSep 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING SHOULDER ARTHROSCOPY PROCEDURE, THE DEVICE WAS NOT WORKING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. PRELIMINARY INVESTIGATION HAS CONCLUDED THAT THIS DEVICE WAS SUBMITTED TO TORQUE AND FORCE, WHICH CAUSED THE DISTAL PORTION OF THE DEVICE TO BREAK, MAKING IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8976731 ↗
• MalfunctionAug 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING SURGERY, WHILE INSERTING THE ANCHOR INTO THE BONE, THE DEVICE'S INSERTION SHAFT BROKE. SINCE THE ORIGINAL ANCHOR COULD NOT BE SCREWED IN COMPLETELY, IT WAS EXTRACTED. A BACK-UP DEVICE WAS USED. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952636 ↗
• MalfunctionAug 16, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE TWINFIX ULTRA INSERTER WAS PARTIALLY DAMAGED AS IT CRACKED INSIDE OF THE PATIENT. THERE WERE NOT ANY FRAGMENTS TO BE REMOVED. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE IN A TIMELY MANNER. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8900887 ↗
• MalfunctionMay 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE FAILED. NO SURGICAL DELAY OR PATIENT INJURIES WERE REPORTED AND A BACK-UP DEVICE WAS AVAILABLE. RESULTS OF INVESTIGATION FOUND THE ANCHOR TO BE BROKEN AND WITH PRESENCE OF HUMAN MATTER IN ITS THREADS. AS A RESULT, IT CAN BE CONCLUDED THAT ANCHOR BROKE IN THE PATIENT WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654387 ↗
• MalfunctionMay 28, 2019Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE INSERTER BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8646929 ↗