BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 4808613 · Received June 1, 2015

    Report

    Report Number
    0002249697-2015-01755
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 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

    AN EVENT REGARDING WELD FAILURE AND PIN DISSOCIATION OF THE MODULAR CAPTURE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION COULD NOT BE PERFORMED AS NO DEVICE WAS RETURN FOR ANALYSIS, FORM THE REPORTED EVENT IT WAS IDENTIFIED AS A CONFIRMED THE EVENT. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL GOODS CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN SIMILAR REPORTED EVENTS. CONCLUSIONS: 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.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THAT WHILST INSPECTING THEIR DISTAL CAPTURE 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 HAS REPORTED THAT WHILST INSPECTING THEIR DISTAL CAPTURE 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
    353108 MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH ER6ED9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other