TWINFIX 7210302Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010495433), received between May 7, 2021 and Dec 5, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2022Break; Break

  IT WAS REPORTED THAT DURING A TENDON CLOSURE IN RADIAL HEAD REPLACEMENT, THE SURGEON TIED THE SUTURE OF THE TWINFIX AND THE SUTURE BROKE. IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921685 ↗
• MalfunctionMay 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE IN A QUADRICEPS SUTURE, THE WIRE OF THE ANCHOR HAD CAME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A COMPETITOR BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794860 ↗
• MalfunctionMay 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE IN A QUADRICEPS SUTURE, THE WIRE OF THE ANCHOR HAD CAME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A COMPETITOR BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794770 ↗

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.