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NA 311.349Recalls & reported problems

Synthes GmbH · TAP FOR 3.5MM CANCELLOUS BONE SCREWS/50MM CALIBRATION · 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 10705034768670), received between Jun 29, 2020 and Jun 29, 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.

  • MalfunctionJun 29, 2020Break; Break

    WHILE INSERTING ALL 4 SCREWS, THE SURGEON FELT THAT THEY WERE LOOSENING. ONCE INSERTED, THE SCREWS WERE SECURE AND THE PROCEDURE WAS CONTINUED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10206698 ↗

Other TAP, BONE devices

All TAP, BONE devices →

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