BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 4714851 · Received April 21, 2015

    Report

    Report Number
    0002249697-2015-01319
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 30, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. THE SUBJECT DEVICE HAS BEEN IDENTIFIED AS WITHIN THE SCOPE OF NC PR AND RELATED CAPA PR. A SUPPLIER MANUFACTURING NONCONFORMANCE HAS BEEN IDENTIFIED AND INVESTIGATED UNDER THE REFERENCED NC AND CAPA RECORDS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SALES REP, (B)(4) HAS REPORTED ON BEHALF OF THE CUSTOMER, (B)(6)., THAT WHILST CARRYING OUT THE INSPECTION PROCESS AS PART OF RA 2014-169, A NON CONFORMING TRIATHLON DISTAL CAPTURE ASSEMBLY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE SALES REP, (B)(6), HAS REPORTED ON BEHALF OF THE CUSTOMER, (B)(6), THAT WHILST CARRYING OUT THE INSPECTION PROCESS AS PART OF (B)(6), A NON CONFORMING TRIATHLON DISTAL CAPTURE ASSEMBLY WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264218 MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH ER6KA7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other