BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC Ø0.6-3.2 F/COMPACT AIR DRIVE+POWER DR

    MDR report key: 4102597 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-00805
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    February 11, 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

    ADDITIONAL NARRATIVE: 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 ADAPTOR IS BLOCKED AND WITH THE FITTING PINS BROKEN, POSSIBLY DUE TO AN EXCESSIVE FORCE USED AND/OR INCORRECT MOVEMENTS IN THE PROCEDURE. THIS SITUATION CREATED AN EXCESS OF LOAD ON THE ADAPTOR AND AFTER THAT DAMAGING THE PARTS. PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR AN UNKNOWN REASON. DURING THE SERVICE TECHNICIAN FOUND THAT THE FITTING PINS OF THE ADAPTOR WERE BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581538 QC Ø0.6-3.2 F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 6595

    Patients

    Seq Age Sex Outcome Treatment
    1