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PROSTEP MICA 57S100MTRecalls & reported problems

Wright Medical Technology, Inc. · First Met Translator · 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 00889797071994), received between Aug 19, 2022 and Aug 19, 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
  • Fracture1

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.

  • MalfunctionAug 19, 2022Break; Fracture; Break; Fracture

    THE TRANSLATOR WAS BROKEN WHILE TRYING TO TRANSLATE THE OSTEOTOMY SITE DURING A GREAT TOE BUNION SURGERY. OTHER INSTRUMENTATION WAS USED TO TRANSLATE THE MET HEAD LATERALLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15260433 ↗

Other GAUGE, DEPTH devices

All GAUGE, DEPTH devices →

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