BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW & MICRO SAGISAW

    MDR report key: 22406 · Received May 11, 1995

    Report

    Report Number
    22406
    Event Type
    Malfunction
    Date Received
    May 11, 1995
    Date of Event
    May 1, 1995
    Report Date
    May 11, 1995
    Manufacturer
    ZIMMER, INC.
    Product Code
    GDR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE (PODIATRIC) SMALL METAL FRAGMENT DROPPED FROM SAW INTO OPEN WOUND. INSTRUMENT CHECKED BY STERILE SUPPLY AND WAS NOTED TO HAVE BEEN DECONTAMINATED PRIOR TO SURGERY. EQUIPMENT RETURNED TO MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAW & MICRO SAGISAW SAW & MICRO SAGISAW GDR ZIMMER, INC. 2316

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other