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NA 03.315.700Recalls & reported problems

Synthes GmbH · 1.0MM/1.3MM SCRWDRIVER BLADE FOR RAISED HD SCRW/HEX CO/86MM · Class 1

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

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 10887587073590), received between Oct 20, 2022 and Oct 20, 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. 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 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.

  • MalfunctionOct 20, 2022Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW HEAD BROKE OFF THE RAISED SCREW HEAD BLADE AND WAS STUCK IN THE SOCKET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.0MM/1.3MM SCRWDRIVER BLADE FOR RAISED HD SCRW/HEX CO/86MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15637811 ↗

Other SCREWDRIVER, SKULLPLATE devices

All SCREWDRIVER, SKULLPLATE devices →

Sources and updates

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