BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II

    MDR report key: 4101551 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-00972
    Event Type
    Malfunction
    Date Received
    September 19, 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. 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 THE TRIGGER WAS NOT FUNCTIONING PROPERLY AND ROTATION WAS BELOW NORMAL. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE DEVICE FOR SERVICE. DURING THE INSPECTION THE INVESTIGATOR FOUND THE REVERSE TRIGGER WAS LOCKED AND THE ROTATION WAS BELOW NORMAL. THIS IS REPORT 1 OF 1 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584286 COMPACT AIR DRIVE II HWE SYNTHES GMBH 27436

    Patients

    Seq Age Sex Outcome Treatment
    1