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NA MWH113Recalls & reported problems

Tornier, Inc. · Retractor Prosthesis · 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 00846832091492), received between Jan 25, 2023 and Jan 25, 2023 — 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.

  • MalfunctionJan 25, 2023Break; Fracture; Break; Fracture

    IT WAS REPORTED THAT THE TIP OF THE PROSTHESIS REDUCER BROKE OFF AND WAS LEFT IN THE PATIENT UNINTENTIONALLY. THE PATIENT WAS BROUGHT BACK INTO THE SURGERY TO REMOVE THE BROKEN PIECE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16244279 ↗

Other RETRACTOR devices

All RETRACTOR devices →

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