BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03835

    MDR report key: 3192607 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03835
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IMPLANT AND EXPLANT DATES WERE INCORRECTLY REPORTED ON INITIAL MEDWATCH. BOTH DATES SHOULD BE BLANK, AS THE DEVICE WAS NEVER IMPLANTED THEREFORE THERE WOULD BE NO EXPLANT DATE AS WELL.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHILE THE SURGEON WAS TIGHTENING THE ZIPFIX WITH HIS HANDS IT WAS BROKEN AND HAD TO REMOVE IT. REPORTEDLY THIS HAPPENED WITH FIVE ZIPFIX DEVICES. NO PATIENT HARM OCCURRED AS A RESULT OF THIS EVENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294024 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1