BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 7324357 · Received March 8, 2018

    Report

    Report Number
    1045834-2018-50451
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    January 1, 2018
    Report Date
    February 8, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    ERL
    UDI-DI
    845384010791
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THAT THE MOTOR DEVICE HOSE ASSEMBLY HAD A HOLE IN THE HOSE APPROXIMATELY TWO INCHES PROXIMALLY OF THE SWIVEL ASSEMBLY, WHICH WAS CONSISTENT WITH HAVING RUPTURED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE OUTER HOSE CARRIED THE RETURN AIR BACK FROM THE HANDPIECE TO THE HOSE MUFFLER TO EXHAUST. IT WAS DETERMINED THAT THE OUTER HOSE COULD BE RESTRICTED BY OCCLUDING IT (LIKE STEPPING ON, LEANING ON, CLAMPING ON) CAUSING AIR PRESSURE TO BUILD. IT WAS DETERMINED THAT IF THE OUTER HOSE WAS RESTRICTED, THEN THE AIR PRESSURE COULD BE RELIEVED BY THE PRESSURE RELIEF VALVE (PRV) IF THE OCCLUSION WAS PROXIMAL OF THE PRV. HOWEVER, IF THE OUTER HOSE WAS OCCLUDED DISTALLY OF THE PRV, THEN THE PRESSURE COULD BE RELIEVED AND THE OUTER HOSE COULD RUPTURE FROM PRESSURE BUILD-UP. IT WAS DETERMINED THAT THE THE CAUSE FOR THE OCCLUSION WAS NOT DETERMINED BUT WOULD HAVE OCCURRED DISTALLY OF THE PRV 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 EQUIPMENT MAINTENANCE, IT WAS OBSERVED THAT THE MOTOR DEVICE HAD A RUPTURED HOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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
    167469 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES PRODUCTS LLC NA 845384010791

    Patients

    Seq Age Sex Outcome Treatment
    1