BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC F/DHS/DCS TRIPLE REAMERS F/TRS

    MDR report key: 4092034 · Received September 16, 2014

    Report

    Report Number
    8030965-2014-00716
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    November 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, IT WAS REVEALED THAT THE COUPLING TOOL SIDE PART WAS MISSING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 12/18/2012. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN FOUND A SHAFT ¿ POSI PIN LOOSE, COUPLING TOOL SIDE PART MISSING, AND FAULTY PRODUCTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571548 QC F/DHS/DCS TRIPLE REAMERS F/TRS HWE SYNTHES GMBH 1082

    Patients

    Seq Age Sex Outcome Treatment
    1