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NA SD03.110.010Recalls & reported problems

Synthes GmbH · SET SCREW FOR PLATE HOLDER · 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 10886982274151), received between Sep 3, 2021 and Sep 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1

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.

  • MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SIDE SET SCREW WOULD NOT FIT IN THE DISTAL RADIUS PLATE HANDLE SO IT COULD NOT BE ASSEMBLED OR USED UPON RECEIPT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SET SCREW FOR PLATE HOLDER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12421968 ↗

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

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