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MatrixMIDFACE 03.505.027Recalls & reported problems

Synthes GmbH · Ø1.25MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMDFACE · Class 2

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 10887587013428), received between Nov 15, 2022 and Nov 15, 2022 — 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 Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 15, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT BROKE INSIDE THE PATIENT¿S MOUTH AS THE SURGEON WAS DRILLING A HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.25MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMDFACE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15797816 ↗

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.