BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS LP MOTOR ASSEMBLY

    MDR report key: 4183244 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14379
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    December 19, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(4) 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. DEVICE CAME IN FOR SERVICE AND WAS REPAIRED BY TECHNICIAN. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR REPAIR. DURING THE INSPECTION THE TECHNICIAN FOUND IT DOES NOT ROTATE AND THE HOSE WAS OUTDATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660690 MICROMAX-PLUS LP MOTOR ASSEMBLY EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL ERL DEPUY SYNTHES POWER TOOLS 050000250935

    Patients

    Seq Age Sex Outcome Treatment
    1