BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT RASP HANDLES

    MDR report key: 1981669 · Received January 12, 2011

    Report

    Report Number
    2249697-2011-00043
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHAH
    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 EVALUATION: 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 BACK 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). ACCORDING TO THE PRODUCT BULLETIN, NO PER IS REQUIRED FOR THESE RETURNED DEVICES.

    Description of Event or Problem · 1

    IN RELATION TO REGULATORY ACTION (B)(4), THE CUSTOMER REPORTED VIA THE CUSTOMER RESPONSE FORM THAT 2 RASP HANDLES FAILED INSPECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention