BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDAN HEX SCREWDRIVER INSERT

    MDR report key: 7529802 · Received May 21, 2018

    Report

    Report Number
    3008021110-2018-00041
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Manufacturer
    HPF
    Product Code
    HXX
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRE-EXISTING DEFECTS WERE FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE LOT# 2015H8866 INVOLVED, ON A TOTAL OF (B)(4) SCREW DRIVERS MANUFACTURED WITH THIS LOT#. NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT#. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE SEIZURE BETWEEN SCREWDRIVER - CODE 9084.20.310, LOT# 2015H8866 - AND L=20 MM BONE SCREW - CODE 8420.15.010, LOT# 201714562. ACCORDING TO THE INFO REPORTED, SCREW DRIVER COULD NOT RELEASE THE 20 MM SCREW AFTER LOCKING THE SCREW ITSELF TO THE DELTA PF ACETABULAR CUP IMPLANTED LEADING TO 15-30 MINUTES OF PROLONGED SURGERY TIME. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373846 CARDAN HEX SCREWDRIVER INSERT CARDAN HEX SCREWDRIVER INSERT HXX HPF 9084.20.310 2015H8866

    Patients

    Seq Age Sex Outcome Treatment
    1