TWINFIX 72203784Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885554029277), received between Feb 5, 2019 and Feb 17, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY, SOME OF THE TWINFIX NEEDLES FELL OFF WHEN USED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME 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

  MAUDE report 11336978 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY, SOME OF THE TWINFIX NEEDLES FELL OFF WHEN USED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME 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

  MAUDE report 11336977 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY, SOME OF THE TWINFIX NEEDLES FELL OFF WHEN USED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME 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

  MAUDE report 11336976 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY, SOME OF THE TWINFIX NEEDLES FELL OFF WHEN USED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME 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

  MAUDE report 11336975 ↗
• MalfunctionMay 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT TWO NEEDLES WERE RELEASED FROM THE THREAD DURING THE SURGICAL PROCEDURE USING THE TWIN-FIX TITANIUM ANCHOR. IT IS UNKNOWN IF THERE WERE DELAYS AND HOW WAS THE PROCEDURE COMPLETED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10077622 ↗
• MalfunctionFeb 5, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ANCHOR SNAPPED INSIDE OF THE PATIENT AND RETRIEVED. IT IS AVAILABLE TO BE COLLECTED FOR INSPECTION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307680 ↗