BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 4111320 · Received September 23, 2014

    Report

    Report Number
    8030965-2014-00825
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. 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, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE THAT THE MOTOR HAS THE PRESSURE PIN BROKEN, POSSIBLY BECAUSE OF THE EXCESSIVE FORCE AND/OR INCORRECT MOVEMENTS IN THE PROCEDURE WHERE THERE IS A LOAD EXCESS NEAR THE BUSHING AND AFTERWARDS THE BREAK OF THE PRESSURE PIN AND EVEN THE KIT DEFORMATION. PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INVERSE WAS BLOCKED. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590763 CAD II HWE SYNTHES GMBH 30729

    Patients

    Seq Age Sex Outcome Treatment
    1