BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE

    MDR report key: 3123646 · Received May 22, 2013

    Report

    Report Number
    8030965-2013-02309
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS OF THIS HOUSING WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS DHR REVIEW IS INDETERMINATE AS THE PROVIDED PART/LOT COMBINATION IS INCORRECT AND BECAUSE THE HISTORY OF THE MACHINE IS UNKNOWN AT SYNTHES (B)(4) AS THIS IS DOCUMENTED IN THE LOCAL SERVICE CENTRE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CODES: ERL, HBE. THE DEVICE WAS DISASSEMBLED WHEN RECEIVED. THE INVESTIGATION OF THE DEVICE SHOWS THAT THE DRIVING SHAFT WAS DEFORMED DURING A MECHANICAL OVERLOADING SITUATION. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY MECHANICAL OVERLOAD.

    Description of Event or Problem · 1

    DURING SURGERY FOR A MANDIBLE RESECTION ON (B)(6) 2013, THE E-PEN RECIPROCATING SAW ATTACHMENT STOPPED WORKING. THE SURGEON HAD TO USE A DIFFERENT SAW ATTACHMENT ADDING AN EXTRA 10 MINUTES TO THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226044 RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE DZI SYNTHES GMBH 1960385

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR