BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK WITH KEY/DRILL SPEED FOR TRAUMA RECON SYSTEM

    MDR report key: 3023916 · Received March 27, 2013

    Report

    Report Number
    2520274-2013-01719
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE COMPLAINT CLOSED WITHOUT REPORT BECAUSE NO MATERIAL HAS BEEN RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT ON (B)(6) 2013, WHEN THE SURGEON CONNECTED THE BATTERY TO THE TRAUMA RECON SYSTEM IN PRE-OP, WHITE OIL WOULD LEAK WHEN AN ATTACHMENT WAS CONNECTED TO THE MAIN BODY OF THE TRS. THIS IS 3 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127214 CHUCK WITH KEY/DRILL SPEED FOR TRAUMA RECON SYSTEM HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1