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TWINFIX 72202623Recalls & reported problems

Smith & Nephew, Inc. · TWINFIX ULTRA 4.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE · Class 2 · Implant

All models of TWINFIX (48)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010647528), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 malfunction.

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

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

Device problems

  • Material Separation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 7, 2019Material Separation; Material Separation

    IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE 4.5 MM TWINFIX ULTRA PK ANCHOR BROKE WHILE HAMMERED. IT IS UNKNOWN IF ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE, BUT IT IS UNKNOWN IF ANOTHER BONE HOLE HAD TO BE DRILLED. THE SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9164827 ↗

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Sources and updates

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