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NA 311.19Recalls & reported problems

Synthes GmbH · TAP FOR 2.0MM CORTEX SCREWS 54MM · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982187291), received between Oct 14, 2019 and Apr 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2

Patient problems

  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 16, 2020Break; Break

    IT WAS REPORTED THAT ON MARCH 24, 2020, THE TWO (2) TAPS FOR CORTEX SCREWS WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9968589 ↗
  • MalfunctionOct 14, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, A TAP FOR CORTEX SCREWS WAS NOTED TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 FOR 1 (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9186136 ↗

Other DRIVER, WIRE, AND BONE DRILL, MANUAL devices

All DRIVER, WIRE, AND BONE DRILL, MANUAL devices →

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