BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 4100061 · Received September 18, 2014

    Report

    Report Number
    1045834-2014-12901
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    DURING SUBSEQUENT FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED. THE REPORTER STATED THAT THERE WAS A TEN MINUTE DELAY TO THE SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SPARE DEVICE. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, THE REPORTER STATED THE EVENT OCCURRED IN (B)(6) 2014. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD NO ROTATION. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE GEAR BOX AND BEARINGS GOING BAD FROM NORMAL WEAR AND SERVICING OVER TIME. 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 THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE COMPACT SPEED REDUCER DEVICE WAS FREEZING UP WHILE IN USE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF 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
    577841 PERFORATOR DRIVER W/HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER HBE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1