TWINFIX 72202893Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010652287), received between Sep 8, 2018 and Feb 22, 2026 — classified as 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF RECONSTRUCTION THE TWINFIX ANCHOR BROKE AND RETRIEVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410821 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, AFTER THE TWINFIX ANCHOR WAS PLACED IN THE PATIENT AND THE STITCHES WERE MADE, THE TWO THREADS BROKE WHEN THE KNOT WAS TIED. THE DEVICE WAS COMPLETELY REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152302 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ULTRA ANCHOR FAILED. THE END PART OF THE IMPLANT HOLDER BROKE DURING THE SCREWING OF THE ANCHOR. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801023 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO TWINFIX ULTRA ANCHOR FAILED IN THE SAME WAY. THE END PART OF EACH IMPLANT HOLDER BROKE DURING THE SCREWING OF THE 2 ANCHORS. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799478 ↗
• InjuryMar 13, 2024Break; Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, WHEN THE TWINFIX ULTRA WAS INSERTED AND SCREWED IN, IT BROKE INSIDE OF THE PATIENT, LEAVING HALF OF THE IMPLANT INSIDE OF THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 18895335 ↗
• InjuryNov 23, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHEN THREADING THE 4.5MM TI TWINFIX ULTRA ANCHOR, IT GAVE RESISTANCE IN THE BONE AND BROKE AT THE END OF THE THREAD. THE MATERIAL WAS COMPLETELY REMOVED, WITH THE AID OF TWEEZERS. THE SURGEON USED A PERFORATOR WITH AN AUXILIARY WIRE TO FACILITATE THE ENTRY OF THE MATERIAL. THE SURGERY WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15857710 ↗
• InjuryJun 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, DUE TO THE PATIENTS INJURY, IT WAS DIFFICULT TO PLACE THE TWINFIX ANCHOR. AFTER HITTING THE ANCHOR WITH A HAMMER TO INSERT IT, THE ANCHOR FRACTURED. IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. THE PATIENT'S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687900 ↗
• InjuryDec 16, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, WHEN IMPACTING THE TWINFIX ANCHOR ON THE PATIENT'S PATELLA, THE TIP OF THE ANCHOR BROKE. ALL THE BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019382 ↗
• InjuryNov 17, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING PROCEDURE, THE ANCHOR OF THE TWINFIX WAS FIXED AND WHEN TYING THE FIRST KNOT, THE TWINFIX ANCHOR LOOSENED. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832253 ↗
• InjuryNov 17, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING SHOULDER ARTHROSCOPY, THE ANCHOR OF THE TWINFIX WAS FIXED AND WHEN TYING THE FIRST KNOT, THE TWINFIX ANCHOR LOOSENED. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832211 ↗
• MalfunctionMay 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY, WHEN INSERTING THE ANCHOR OF THE TWINFIX ULTRA IN THE PATIENT AND PASSING THE STITCHES ON THE TENDON, THE ANCHOR ENDED UP LOOSENING FROM THE BONE AND FAILED TO BE IMPLANTED IN THE PATIENT. PATIENT WITH POOR BONE QUALITY. UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900577 ↗
• InjuryMay 20, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A CUFF SUTURE RECONSTRUCTION PROCEDURE THE TWINFIX ULTRA WERE USED, DUE TO POOR BONE QUALITY IT WAS NOT FULLY INSERTED AND THE INTRODUCTORY CABLES OF THE ANCHORS WERE OPENED. IT WAS DECIDED TO PERFORM AN OPEN SURGERY FOR THE TOTAL OF THE MATERIALS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE HOWEVER, A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856994 ↗
• InjuryMay 20, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A CUFF SUTURE RECONSTRUCTION PROCEDURE THE TWINFIX ULTRA WERE USED, DUE TO POOR BONE QUALITY IT WAS NOT FULLY INSERTED AND THE INTRODUCTORY CABLES OF THE ANCHORS WERE OPENED. IT WAS DECIDED TO PERFORM AN OPEN SURGERY FOR THE TOTAL OF THE MATERIALS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE HOWEVER, A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856984 ↗
• InjuryJan 5, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TWIN FIX BROKE OFF. BACKUP DEVICE WAS AVAILABLE TO COMPLETED WITH THE SAME DEVICE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11119651 ↗
• InjuryDec 17, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A PCL RECONSTRUCTION SURGERY, THE HANDLE OF A TWINFIX WAS AUTOMATICALLY DISCONNECTED WHEN ANCHOR WAS SCREW-IN FOR 1/2. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE PLACED ON THE ORIGINALLY DRILLED BONE HOLE, SO THE FAULTY ONE HAD TO BE REMOVED. THIS OCCURRED WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028024 ↗
• MalfunctionOct 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE PACKAGE OF THE TWINFIX ANCHOR WAS BEING OPENED, IT WAS FOUND TO BE SEPARATED FROM THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. 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 10624714 ↗
• MalfunctionAug 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TWINFIX WAS NOT STERILIZED. SURGERY WAS COMPLETED BY USING A SMITH AND NEPHEW BACK-UP DEVICE WITH NO SIGNIFICANT DELAY REPORTED. THE DEVICE WAS NOT USED IN THE PATIENT AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10372449 ↗
• MalfunctionDec 31, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE TWINFIX WAS FOUND RUST AT THE SCALE MARK OF METAL INSERTER UNDER ARTHROSCOPY. IT IS UNKNOWN IF THERE WAS A DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS 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 9535746 ↗
• InjuryNov 28, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A RIGHT SHOULDER ARTHROSCOPIC SYNOVIUM CLEANING, RIGHT SHOULDER GLENOID LIP REPAIR AND AN ACROMIOPLASTY WERE PERFORMED ON (B)(6) 2019; A TEAR WAS FOUND IN FRONT OF RIGHT LABRUM AND A TWINFIX ANCHOR WAS IMPLANTED. THE PATIENT FOUND SHOULDER DISCOMFORT AFTER SURGERY FOR ONE MONTH. THE PATIENT WENT TO THE HOSPITAL FOR TREATMENT AGAIN ON (B)(6) 2019 AND IT WAS FOUND THAT THE TWINFIX ANCHOR WAS LOOSENED AND DISPLACED AND THE PERIPHERAL TISSUE WITH NECROSIS. A REVISION SURGERY WAS PERFORMED TO CLEAN UP THE NECROTIC TISSUE AND REMOVE THE DISPLAYED ANCHOR. IT WAS STATED THAT BECAUSE OF THE PAIN, THE PATIENT COULD NOT SLEEP OR MOVE AND THE DAMAGED TISSUE WILL NOT BE RECOVERED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9390478 ↗
• InjuryAug 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A REVISION SURGERY DUE TO BAD QUALITY THE ANCHOR EXPIRED AND IT WAS FULLY REMOVED. NO DELAY AND BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881907 ↗
• MalfunctionJul 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN SUTURING ONE OF THE THREADS BROKE. THE PROCEDURE WAS COMPLETED WITH NO DELAY OR PATIENT INJURY REPORTED. IT IS UNKNOWN IF A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8790855 ↗
• MalfunctionApr 10, 2019Break

  IT WAS REPORTED THAT PART OF THE ANCHOR BROKE, SO THE ANCHOR CAME OUT OF THE BONE. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE TO COMPLETE THE PROCEDURE AND NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501499 ↗
• MalfunctionMar 13, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY WITH A NORMAL AWL, THE ANCHOR CANNOT BE IMPLANTED. AN ADDITIONAL BONE HOLE WAS MADE TO COMPLETE THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8416186 ↗
• MalfunctionDec 11, 2018Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSERTION OF THE ANCHOR INTO THE PATIENT'S BONE, THE STEM OF THE SCREWDRIVER HAS DETACHED IN ITS DISTAL PART, MAKING IT IMPOSSIBLE TO INSERT AND REMOVE THE ANCHOR FROM THE BONE. THE SURGEON REMOVED THE ANCHOR USING A LARGE FORCEP. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152473 ↗
• MalfunctionSep 18, 2018Break

  IT WAS REPORTED THAT DURING THE INSERTION OF THE ANCHOR INTO THE PATIENT'S BONE THE ANCHOR BROKE EVEN THOUGH A HOLE WAS USED TO INITIATE THE FIXATION. THERE WAS A DELAY OF 40 MINUTES. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886114 ↗