BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 4765199 · Received May 12, 2015

    Report

    Report Number
    0002249697-2015-01510
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 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 NO OTHER EVENTS FOR THE REPORTED LOT. THE MODULAR CAPTURE TRIGGER CROSS PINS WERE IN PLACE AND THE WELDS WERE INTACT. 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 SALES REP HAS REPORTED ON BEHALF OF THE CUSTOMER, (B)(6), THAT WHILST CARRYING OUT THE INSPECTION PROCESS AS PART OF RA 2014-169, TWO NON CONFORMING TRIATHLON DISTAL CAPTURE ASSEMBLIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE SALES REP HAS REPORTED ON BEHALF OF THE CUSTOMER, (B)(6), THAT WHILST CARRYING OUT THE INSPECTION PROCESS AS PART OF RA 2014-169, TWO NON CONFORMING TRIATHLON DISTAL CAPTURE ASSEMBLIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309061 MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH ER5NE4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other