Skip to content

HOFFMANN 4922-9-941SRecalls & reported problems

Stryker GmbH · Sterile Field Kit · 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 07613327008005), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

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 3, 2020Material Fragmentation; Material Fragmentation

    AS REPORTED: "WHEN I USED THE DRILL BRACE AND INSERTED THE APEX PIN, A PIECE OF METAL CAME OUT OF THE DRILL BRACE. THE OPERATION CONTINUED AS IT WAS AND WAS COMPLETED WITHOUT ANY PROBLEMS."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10781535 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

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