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ULTRABRAID 7210915Recalls & reported problems

Smith & Nephew, Inc. · ULTRABRAID 2 COBRAID 38 LENGTH SINGL · Class 2 · Implant

All models of ULTRABRAID (11)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010511935), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 injury.

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

  • Break1

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.

  • InjurySep 3, 2020Break; Break

    IT WAS REPORTED THAT DURING SURGERY, THE ULTRABRAID SUTURE BROKE INSIDE THE PATIENT WHEN ATTACHING TO THE ULTRABUTTON PLAQUE AT THE MENISCAL ROOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP 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 Known Impact Or Consequence To Patient

    MAUDE report 10491395 ↗

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices

All SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices →

Sources and updates

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