BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT RASP HANDLES

    MDR report key: 1984027 · Received January 14, 2011

    Report

    Report Number
    2249697-2011-00050
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    2249697-11/11/10-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: THE INVESTIGATION CONCLUDED THAT THE EVENT IS RELATED TO OTHER PREVIOUS EVENTS FOR THIS PRODUCT WHERE THE HANDLE FRACTURED INFERIOR TO THE STRIKE PLATE. IN SOME OF THESE EVENTS THE STRIKE PLATE THEN DISASSOCIATED FROM THE HANDLE. INVESTIGATIONS OF THESE PREVIOUS EVENTS CONCLUDED THAT THE ROOT CAUSE IS DESIGN RELATED. THE POSITION OF THE THROUGH HOLE, VERSION HOLES AND SUPERIOR LIGHTENING HOLE, INFERIOR TO THE STRIKE PLATE, DO NOT DISCOURAGE CRACK INITIATION AND PROPAGATION. NO SIMILAR EVENTS HAVE BEEN REPORTED FOR PRODUCTS MANUFACTURED AFTER IMPLEMENTATION OF THIS DESIGN CHANGE. IF CRACKS ARE FOUND THE HANDLES ARE TO BE RETURNED TO STRYKER ORTHOPAEDICS UNDER (B)(4).

    Description of Event or Problem · 1

    THE DEVICES WERE INSPECTED BY THE CUSTOMER AND THE ITEM FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT RASP HANDLES INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention