BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA BROACH SIZE 0

    MDR report key: 2739459 · Received September 7, 2012

    Report

    Report Number
    3005180920-2012-00049
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    July 27, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ANOMALIES FOUND: THE PRODUCTION STEPS WERE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE QUADRA BROACH IS TO BE USED TO IMPLANT QUADRA IMPLANTS, CLEARED UNDER K072857 (QUADRA S), K082792 (QUADRA H) AND K083558 (QUADRA C). THE TIP OF THE BROACH (SIZE 0) BROKE IN THE INTRA-MEDULLARY CHANNEL WHILE BROACHING AND IT WAS NOT REMOVED. (B)(4).

    Description of Event or Problem · 1

    THE TIP OF THE BROACH (SIZE 0) BROKE IN THE INTRA-MEDULLARY CHANNEL WHILE BROACHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA BROACH SIZE 0 HIP REUSABLE INSTRUMENT JDI MEDACTA INTERNATIONAL, SA 084743

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other