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NA 422.391Recalls & reported problems

Synthes GmbH · 5.0MM TI LOCKING SCREW SELF-DRILLING 18MM · Class 2 · Implant

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 10886982215857), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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

  • Incomplete or Missing Packaging1

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 8, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

    IT WAS REPORTED THAT THERE WERE MULTIPLE MISSING SCREWS IN AN EVALUATIONS SET. SET WAS NEVER USED OR STERILIZED. TRAYS NEVER ENTERED OPERATING ROOM SUITE. MISSING SCREWS IN TRAYS WERE DISCOVERED WHEN TOTE WAS OPENED TO CHECK CONDITION OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7324289 ↗

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

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