BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 5982 · Received April 5, 1993

    Report

    Report Number
    32962-1993-00003
    Event Type
    Malfunction
    Date Received
    April 5, 1993
    Date of Event
    January 25, 1993
    Report Date
    January 27, 1993
    Manufacturer
    ZIMMER
    Product Code
    LRZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DR. WAS TIGHTENING DOWN THE LAST OF THREE SCREWS INTO AN ACETABULAR CUP SHELL WHEN THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. IT IS UNKNOWN WHICH SCREW IT WAS BUT THE THREE USED ARE 1 EACH AND 2 EACH. THE DR. ATTEMPTED TO REMOVE THE BROKEN PIECE BUT COULD NOT GET IT OUT. HE STATED THAT IF HE COULD GET IT OUT AND SINCE THE LINER GOES OVER IT AND FITS FLUSH, WE'LL LEAVE IT IN. NO SERIOUS ILLINESS OR SERIOUS INJURY REPORTEDDEVICE 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. 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 HEXHEAD SCREWDRIVER/UNIVERSAL JOINT 2.5MM DIA. LRZ ZIMMER 68945000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other