TWINFIX 7210301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010533845), received between Jan 8, 2019 and Mar 23, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2022Break; Break

  IT WAS REPORTED THAT DURING A WRIST SURGERY, THE TWINFIX ANCHOR BROKE AT THE JUNCTION OF ANCHOR AND SUTURE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865447 ↗
• MalfunctionNov 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A DISTAL REINSERTION OF THE RIGHT BICEPS BRACHIALIS, A TWINFIX TITANIUM ANCHOR WAS BEING INSERTED BUT IT BROKE IN THE PATIENT'S BONE. IT WAS NOT POSSIBLE TO REMOVE THE PIECE WHICH HAD ALREADY BEEN IMPLANTED IN THE PATIENT'S BONE. A CHANGE OF BONE TARGETING ORDER WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. 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 Information

  MAUDE report 10875459 ↗
• InjuryNov 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A DISTAL REINSERTION OF THE RIGHT BICEPS BRACHIALIS, A TWINFIX TITANIUM ANCHOR WAS BEING INSERTED BUT IT BROKE IN THE PATIENT'S BONE. IT WAS NOT POSSIBLE TO REMOVE THE PIECE WHICH HAD ALREADY BEEN IMPLANTED IN THE PATIENT'S BONE. A CHANGE OF BONE TARGETING ORDER WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. 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 Information

  MAUDE report 10875412 ↗
• MalfunctionJan 8, 2019Break

  IT WAS REPORTED THAT DURING PROXIMAL HUMERUS AVULSION SURGERY, THE SUTURE BROKE WHEN KNOTTING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8228767 ↗

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.