BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 4646419 · Received March 31, 2015

    Report

    Report Number
    1045834-2015-10660
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 1, 2015
    Report Date
    March 6, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK965080
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH FOUND THAT THE HOSE WAS DAMAGED BY THE MUFFLER WHICH WAS INDICATIVE OF PULLING ON THE HOSE INSTEAD OF THE MUFFLER TO DISCONNECT IT FROM THE AUTOLUBE AND/OR PULLING THE AUTOLUBE AROUND BY THE HOSE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE COMPONENT DAMAGE CAUSED BY MISUSE / ABUSE AND POSSIBLY USER ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS DOCUMENTED AS (B)(4) IN THE INITIAL REPORT. IT HAS BEEN UPDATED TO (B)(4). BOTH COMMON DEVICE NAME AND DEVICE PRODUCT CODE HAVE BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTION. THE PMA/510K NUMBER WAS DOCUMENTED AS K831756 IN THE INITIAL REPORT. IT HAS BEEN UPDATED TO K965080. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-SURGERY TESTING, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS NOT WORKING. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE REPORTER STATED THAT THE EVENT OCCURRED ON (B)(6) 2015; HOWEVER, THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211772 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1