BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM FLUTED BALL, 15CM

    MDR report key: 4123579 · Received September 26, 2014

    Report

    Report Number
    1045834-2014-13103
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 16, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING THE FIRST THREE MINUTES OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THE CUTTER DEVICE WAS BROKEN WHILE IN USE WITH A BEARING SLEEVE DEVICE. ACCORDING TO THE REPORT, ALL THE BROKEN PIECES OF THE DEVICE WERE REMOVED. THE REPORTER DID NOT SPECIFY WHERE THE PIECES WERE REMOVED FROM. HOWEVER, IT WAS STATED THAT THE EVENT WAS NOT RELEVANT TO THE HEALTH OF THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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
    602221 3MM FLUTED BALL, 15CM DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR HBE DEPUY SYNTHES POWER TOOLS H043089013

    Patients

    Seq Age Sex Outcome Treatment
    1 BEARING SLEEVE DEVICE