BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 4795373 · Received May 26, 2015

    Report

    Report Number
    0002249697-2015-01678
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Removal / Correction Number
    2249697-3/20/2015-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL INSPECTION ON THE RETURNED DEVICE IDENTIFIED A FRACTURE WELD ON ONE OF THE PINS. A CAPA DETERMINED ROOT CAUSE AS: IN-PROCESS MANUFACTURING TOLERANCE CHANGE MADE AT SUPPLIER LOCATION WITHOUT FORMAL CHANGE CONTROL PROCESS AND ADEQUATE ASSESSMENT OF DELIVERABLES TO BE IMPLEMENTED. NOTIFICATION TO STRYKER ALSO MISSED DUE TO LACK OF CHANGE CONTROL.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6), HAS REPORTED THAT WHILST INSPECTING THEIR DISTAL CAPRURE ASSEMBLY DEVICES AS PART OF RA 2014-169, THEY HAVE FOUND A NON CONFORMING DEVICE AS DETAILED IN THE INSPECTION BULLETIN.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6), HAS REPORTED THAT WHILST INSPECTING THEIR DISTAL CAPRURE ASSEMBLY DEVICES AS PART OF RA 2014-169, THEY HAVE FOUND A NON CONFORMING DEVICE AS DETAILED IN THE INSPECTION BULLETIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340932 MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH ER6ED9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other