BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4132061 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-01463
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    April 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 ADAPTOR DID NOT FIT WITH THE MOTOR, FITTING PINS WERE BROKEN, THE BEARINGS WERE OXIDIZED, AND THE ADAPTOR MAKES AN UNUSUAL NOISE. THIS WAS ATTRIBUTED TO IMPROPER USE AND FAILURE TO CLEAN PROPERLY. THE DEVICE WAS 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 ADAPTOR DID NOT FIT WITH THE MOTOR, DUE TO SHAVINGS ON THE CONNECTION PART AND FITTING PINS ARE BROKEN, CAUSED BY USE OF EXCESSIVE FORCE AND/OR INCORRECT MOVEMENTS DURING PROCEDURE. THE ADAPTOR HAS AN UNCHARACTERISTIC NOISE, BECAUSE IT HAS OXIDIZED BEARINGS, CAUSED BY A FAIL IN HE CLEANING AND LUBRICATION PROCESS. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610362 QC Ø0.6-3.2 F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 9229

    Patients

    Seq Age Sex Outcome Treatment
    1