BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL, OFFSET - 30° BROACH HANDLE - RIGHT

    MDR report key: 5441750 · Received February 17, 2016

    Report

    Report Number
    3005180920-2016-00042
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 11, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE (B)(6) CHECKED THE IMAGE RECEIVED COMMENTING THAT: WE NEED TO INSPECT THE INSTRUMENT TO DETERMINE THE ROOT CAUSE BECAUSE THE IMAGE IS NOT CLEAR. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 1417341: (B)(4) ITEMS MANUFACTURED AND RELEASED ON JULY 30, 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, THE R AND D PROJECT MANAGER REVIEWED THE VISUAL INSPECTION, BASED ON THE COMMENTS RECEIVED FROM THE SUPPLIER OF THE INSTRUMENTS. THE VISUAL INSPECTION WAS UPDATED AS FOLLOWS: OUR SUPPLIER CONFIRMS US THAT THE PRODUCTION CYCLE OF THESE INSTRUMENT WAS VERIFIED AND THERE WERE NO ANOMALY. THE MORE PLAUSIBLE HYPOTHESIS IS THAT THE SPRING BOX PLUNGERS WERE FLAWED, MAYBE DUE TO AN OCCASIONAL BAD ASSEMBLY.

    Additional Manufacturer Narrative · 1

    ON 09 JUNE 2016 THE (B)(4) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE BALL OF THE SPRING BALL PLUNGER CAME OUT FROM ITS SEAT. THIS IS THE THIRD COMPLAINT WITH THIS ISSUE ON THE NEW VERSION OF THIS HANDLE FROM 2013. ALL THESE THREE HANDLES WERE MANUFACTURED BY OUR EXTERNAL SUPPLIER THAT HAS BEEN CONTACTED TO VERIFY THE PRODUCTION CYCLE.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS BROACHING THE PATIENT'S FEMUR, THE BALL BARING FELL OUT OF THE BROACH HANDLE. THE BALL BARING LANDED ON THE GROUND AND NOT IN THE PATIENT. AT THAT TIME THE SURGEON CONTINUED BROACHING WITH THE OTHER BROACH HANDLE THAT THE SALES AGENT HAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO X-RAYS AVAILABLE. THE BROACH WILL BE RETURNED TO MEDACTA INTERNATIONAL SA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98669 HIP GENERAL, OFFSET - 30° BROACH HANDLE - RIGHT SURGICAL INSTRUMENTS FOR HIP LXH MEDACTA INTERNATIONAL SA 1417341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other