BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTER

    MDR report key: 8864 · Received July 29, 1994

    Report

    Report Number
    8864
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    November 16, 1993
    Report Date
    January 21, 1994
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FEMORAL PUNCH BEING USED IN USUAL FASHION PER OR PERSONNEL. DEVICE SIMPLY BROKE DURING PER REPORTS. CLINICAL ENGINEERING ATTRIBUTES CAUSE OF FAILURE TO BE EXCESSIVE TORQUE APPLIED TO THE HANDLE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, END OF LIFE - PREMATURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL IMPACTER UNIVERSAL HANDLE HWP ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other