BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M 12 IN SS BROAD COMP PLATE

    MDR report key: 3092273 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01519
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRS
    PMA / PMN Number
    K922525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    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 WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. A VISUAL INSPECTION REVEALED THE RETURNED DEVICE TO BE FULLY SHRINK WRAPPED AND A LONG DARK COLORED HAIR PRESENT BENEATH THE SHRINK WRAP ON TOP OF THE CARTON. THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE HAIR FOUND UNDER THE BLISTER PACK WAS CAUSED BY NON STERILE CONDITIONS DURING PACKAGING. CORRECTIVE ACTIONS WERE IMPLEMENTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL CALLED THE CUSTOMER SERVICE OF STRYKER (B)(4) TO REPORT THAT "A HAIR WAS FOUND UNDER THE BLISTER OF THE DEVICE."

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL CALLED THE CUSTOMER SERVICE OF STRYKER (B)(4) TO REPORT THAT "A HAIR WAS FOUND UNDER THE BLISTER OF THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195052 D/M 12 IN SS BROAD COMP PLATE IMPLANT HRS STRYKER ORTHOPAEDICS-MAHWAH 41964701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other