TWINFIX 7210300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010495426), received between Oct 24, 2019 and Oct 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K972326); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR WAS BROKEN DURING INSERTION DUE TO A TORSIONAL FORCE BEING APPLIED GREATER THAN NORMAL, THE BROKEN ANCHOR WAS REMOVED FROM THE PATIENT. NO SIGNIFICANT DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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: Foreign Body In Patient

  MAUDE report 9234550 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972326. One submission often covers many models, so check the product and lot details in each record.

• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.