BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APD 60.000 RPM

    MDR report key: 4113066 · Received September 24, 2014

    Report

    Report Number
    8030965-2014-00928
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    March 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HBB
    PMA / PMN Number
    K093361
    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 MOTOR DID NOT FUNCTION PROPERLY. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT MOTOR HAD STOPPED DURING A SURGERY AND, WHEN SWITCHING ON AGAIN, IT MADE STRANGE NOISE. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593261 APD 60.000 RPM HBB SYNTHES GMBH 2243

    Patients

    Seq Age Sex Outcome Treatment
    1