BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR

    MDR report key: 4143479 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-01257
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    May 21, 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 (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, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE CLAMPING JAW IS BROKEN AND THE ADAPTOR IS WARPED AND WILL NOT FIT INTO THE ENGINE. THIS WAS ATTRIBUTED TO EXCESSIVE HANDLING. THE DEVICE WAS RETURNED UNREPAIRED TO THE CUSTOMER ON 05/27/2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR REPAIR, NO FURTHER INFORMATION WAS PROVIDED. DURING SERVICE IT WAS REPORTED THAT THE CONNECTION PART OF THE DEVICE WAS DISTORTED AND THE CLAMPING JAW WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622328 CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 8067634

    Patients

    Seq Age Sex Outcome Treatment
    1