BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI AIR DRILL

    MDR report key: 4802122 · Received May 28, 2015

    Report

    Report Number
    9612488-2015-10232
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE MOTOR SEIZED, WAS JAMMED, MOVING HEAVY AND RUNNING ROUGH. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE MINI AIR DRILL DEVICE DID NOT WORK. IT WAS FURTHER REPORTED THAT AFTER SWITCHING ON THE DEVICE IT DID NOT FUNCTION. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF DELAYS, 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346045 MINI AIR DRILL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES BETTLACH NA

    Patients

    Seq Age Sex Outcome Treatment
    1