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NA 219974Recalls & reported problems

Medos International Sàrl · Tendon Fork 5.5mm Percent Accuracy Plus or Minus 6 Percent · Class 1

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 10886705021772), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 17, 2020Break; Break

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING STERILIZATION THE TENDON FORK 5.5 MM BROKE. NO PATIENT WAS INVOLVED. THE DEVICE WAS DISCARDED BY THE HOSPITAL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9843293 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.