BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 6147 · Received July 16, 1993

    Report

    Report Number
    34545-1993-00002
    Event Type
    Injury
    Date Received
    July 16, 1993
    Date of Event
    June 10, 1993
    Report Date
    June 18, 1993
    Manufacturer
    ZIMMER
    Product Code
    LRZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING MAGNA-FX SCREWS FROM PATIENT'S LEFT HIP, THE CANNULATED SCREWDRIVER BROKE OFF AT THE END. SURGEON SUBSTITUTED THE CANNULATED SCREWDRIVER (JACOBS CHUCK) WAND THE SHANK BROKE OFF. ASSOCIATE THEN DELIVERED SCREWDRIVER, WHICH ROUNDED OFF AT THE END. SZCREWS REMOVED WITH VICE GRIPS AFTER EXTENDED OPERATIVE TIMEDEVICE NOT 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 USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MAGNA-FX CANNULATED SCREWDRIVER LRZ ZIMMER 00394100

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention