BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    26MM -3MM V40 TRIAL HEAD

    MDR report key: 3023665 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01085
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING THE FRACTURE OF A V40 TRIAL HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. MATERIAL ANALYSIS WAS PERFORMED ON THE REPORTED DEVICE, WHICH CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. NO MEDICAL RECORDS WERE REQUESTED OR RECEIVED DUE TO THE NATURE OF THIS EVENT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES SHOW THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID THE INVESTIGATION CONCLUDED THAT THE REPORTED FRACTURE WAS CAUSED BY MULTIPLE OVERLOAD CONDITIONS. NO MANUFACTURING DEFECTS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BHA, WHEN THE SURGEON WAS CHECKING THE NECK LENGTH ON A FINAL TRIAL, THE TRIAL HEAD BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BHA, WHEN THE SURGEON WAS CHECKING THE NECK LENGTH ON A FINAL TRIAL, THE TRIAL HEAD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126046 26MM -3MM V40 TRIAL HEAD INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SS105091

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other