BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® XMAX

    MDR report key: 4130247 · Received September 30, 2014

    Report

    Report Number
    1045834-2014-13148
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 21, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 DEVICE RPM WAS BELOW SPECIFICATION. THIS WAS ATTRIBUTED TO NORMAL WEAR. MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2012.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MOTOR SPEED AND TORQUE STRENGTH WERE LOW. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607720 ANSPACH® XMAX DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1