BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HANDLE

    MDR report key: 4693 · Received July 31, 1992

    Report

    Report Number
    4693
    Event Type
    Malfunction
    Date Received
    July 31, 1992
    Date of Event
    December 5, 1991
    Report Date
    December 17, 1991
    Manufacturer
    SYNTHES - A-O
    Product Code
    LRZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    HANDLE OF SCREWDRIVER BROKE INTO SEVERAL PIECES WHILE PHYSICIAN WAS REMOVING SCREWS FOR BROKEN PLATEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER HANDLE LRZ SYNTHES - A-O 314.02

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other