BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 6955113 · Received October 17, 2017

    Report

    Report Number
    1045834-2017-12263
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 26, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE HANDPIECE HOSE HAD A HOLE IN THE HOSE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH FOUND THAT THE HOSE ASSEMBLY WAS OBSERVED TO HAVE A HOLE IN THE HOSE APPROXIMATELY 8 INCHES DISTALLY OF THE PRESSURE RELIEF VALVE (PRV) CONSISTENT WITH HAVING RUPTURED. THE OUTER HOSE CARRIES THE RETURN AIR BACK FROM THE HANDPIECE TO THE HOSE MUFFLER TO EXHAUST. THE OUTER HOSE CAN BE RESTRICTED BY OCCLUDING IT (E.G. STEPPING ON, LEANING ON, CLAMPING ON) CAUSING AIR PRESSURE TO BUILD. IT WAS DETERMINED THAT IIF THE OUTER HOSE IS RESTRICTED THE AIR PRESSURE CAN BE RELIEVED BY THE PRESSURE RELIEF VALVE (PRV) IF THE OCCLUSION IS PROXIMAL OF THE PRV. HOWEVER, IF THE OUTER HOSE IS OCCLUDED DISTALLY OF THE PRV THE PRESSURE CANNOT BE RELIEVED AND THE OUTER HOSE CAN RUPTURE FROM PRESSURE BUILD-UP. THE CAUSE FOR THE OCCLUSION WAS NOT DETERMINED BUT WOULD HAVE OCCURRED DISTALLY OF THE PRV. THE ASSIGNABLE ROOT CAUSE OF THE HOSE RUPTURE WAS DETERMINED TO BE COMPONENT DAMAGE DUE TO USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DETERMINED THAT HE HOSE ON THE MOTOR DEVICE WAS RUPTURED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735363 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1