BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.15MM X 22MM SPIRAL ROUTER

    MDR report key: 3240417 · Received July 17, 2013

    Report

    Report Number
    1045834-2013-03373
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES. THE INVESTIGATION IS CURRENTLY IN PROCESS. WHEN THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING INCOMING INSPECTION, IT WAS OBSERVED THAT THERE WAS "RESIDUE IN THE STERILE PACKAGE" OF THE DEVICE. THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALTHOUGH THE REPORTER CLARIFIED THE EVENT OCCURRED IN (B)(6) 2013. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332130 2.15MM X 22MM SPIRAL ROUTER HBC DEPUY SYNTHES POWER TOOLS F533073588

    Patients

    Seq Age Sex Outcome Treatment
    1