TWINFIX 72202896Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010652270), received between Dec 23, 2019 and Aug 4, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2022Break; Break

  IT WAS REPORTED THAT DURING USE THE TWINFIX ULTRA ANCHOR ONCE THE THREAD WAS PULLED IT WAS BROKEN AND THE KNOT COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND 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 15168627 ↗
• InjuryOct 20, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TWINFIX ULTRA BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO 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 Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10708360 ↗
• InjuryJun 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE TWINFIX ULTRA THE SETTING TOOL HAS BROKEN OFF THE ANCHOR ALTHOUGH THE HOLE WAS PREPARED WITH THE APPROPRIATE AWL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. THE DEVICE BROKE OFF INSIDE THE PATIENT'S ANATOMY AS THE INVESTIGATION CONFIRMED THAT THE DEVICE HAD HUMAN MATTER ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121831 ↗
• InjuryJun 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE SETTING TOOL HAD BROKEN OFF THE TWINFIX ULTRA ANCHOR ALTHOUGH THE HOLE WAS PREPARED WITH THE APPROPRIATE AWL. BACK-UP DEVICE WAS AVAILABLE TO COMPLAINT THE SURGERY WITH NO SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10116688 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING RCR PROCEDURE, THE SURGEON HAD A HARD TIME SETTING THE ANCHOR, THE ANCHOR WAS BROKEN WHEN IT WAS BEING INSERTED INTO THE BONE. THE PHYSICIAN STATED THAT THE BONE WAS A BIT HARD, THEREFORE, THE DEVICE BROKE OFF. A DELAY GREATER THAN 30 MINUTES WAS REPORTED DUE TO DEVICE MALFUNCTION. THE SURGEON CHANGED FROM ARTHROSCOPIC TO OPEN IN ORDER TO REMOVE THE ANCHOR FROM THE PATIENT¿S ANATOMY. SURGERY WAS COMPLETED USING A BACK-UP DEVICE. PATIENT INJURIES WERE NOT 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 9514332 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE RCR PROCEDURE, THE ANCHOR OF THE DEVICE BROKE OFF INSIDE THE PATIENT AT SULCUS. THE DOCTOR HAD TO CONVERT TO BE ABLE TO TAKE THE ANCHOR OUT. THE ANCHOR DID NOT GO ALL THE WAY DOWN. THERE WAS A SIGNIFICANT DELAY OF MORE THAN 30 MINUTES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 9511917 ↗