BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOC(TM) STAR 10 DRIVER

    MDR report key: 2493416 · Received March 15, 2012

    Report

    Report Number
    1043534-2012-00249
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 21, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00250.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. VISUALLY EXAMINED. PHOTOGRAPHIC IMAGES MADE. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4), LOT NO: 853126. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY THE TIP BROKE OFF UPON TIGHTENING OF SCREW. THE TIP REMAINS IN THE SCREW HEAD FLUSH AND WOULD BE IMPOSSIBLE TO REMOVE. SURGEON DIDN'T LIKE THE REDUCTION OF BONE SO HE BENT THE PLATE IN ORDER TO "SPIN" THE SCREW OUT. ADDITIONAL SURGERY TIME WAS ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC(TM) STAR 10 DRIVER SMALL JOINT INSTRUMENT HRS WRIGHT MEDICAL TECHNOLOGY, INC. 120853126

    Patients

    Seq Age Sex Outcome Treatment
    1