BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 4123318 · Received September 26, 2014

    Report

    Report Number
    8030965-2014-01495
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    February 4, 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 OUS 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 TECHNICIAN, FOUND THAT THE ADAPTER WAS STUCK IN THE MOTOR DUE TO BURRS ON THE SHAFT AND WORN OUT PUSH BUTTON. THE SHAFT WAS ADJUSTED AND THE PUSH BUTTON REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ADAPTER GOT STUCK IN THE COMPACT AIR DRIVE DURING THE SURGERY. THIS IS REPORT 1 OF 1 FOR EVENT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602746 COMPACT AIR DRIVE II HWE SYNTHES GMBH 23824

    Patients

    Seq Age Sex Outcome Treatment
    1