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NA 2245-10-002Recalls & reported problems

Depuy Orthopaedics, Inc. · GSRS HINGED BLUNT POINT GELPI RETRACTOR · 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 10603295107613), received between Feb 8, 2019 and Feb 8, 2019 — 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

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.

  • MalfunctionFeb 8, 2019Break; Break

    THE INSTRUMENT BROKE DURING ROUTINE CLEANING BEFORE BEING STERILIZED. SOME RUST WAS NOTED INSIDE HINGE WHICH COULD NOT HAVE BEEN SEEN BEFORE THE INSTRUMENT BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8323248 ↗

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.