BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT RASP HANDLES

    MDR report key: 1962925 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01891
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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). ACCORDING TO THE PRODUCT BULLETIN, NO PER IS REQUIRED FOR THESE RETURNED DEVICES.

    Description of Event or Problem · 1

    AS PART OF THE INSPECTION OF THESE DEVICES ACCORDING TO REGULATORY ACTION (B)(4), THE ITEMS FAILED INSPECTION DUE TO BEING BROKEN AND/OR WEAR AND TEAR.

    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