BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II (CAD II)

    MDR report key: 6116449 · Received November 21, 2016

    Report

    Report Number
    8030965-2016-15647
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 22, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER MAINTENANCE, WHICH IS USER ERROR, MISUSE, AND / OR ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT THE COMPACT AIR DRIVE DEVICE, QUICK COUPLING DEVICE AND THE ATTACHMENT DEVICE WERE NOT WORKING. DURING THE PRE-REPAIR DIAGNOSTICS ASSESSMENT, IT WAS DETERMINED THAT THE REVERSE LOCKING MECHANISM WAS BLOCKED ON THE COMPACT AIR DRIVE DEVICE. IT WAS FURTHER DETERMINED THAT THE COMPACT AIR DRIVE DEVICE FAILED FOR CHECK REVERSE LOCKING MECHANISM, CHECK FOR UNTRUE RUNNING, CHECK FOR EXCESSIVE NOISE, AND CHECK THE POWER WITH TEST BENCH AND FOR CHECK STARTING BEHAVIOR. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767362 COMPACT AIR DRIVE II (CAD II) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT DEVICE| QUICK COUPLING DEVICE