BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPAREKEY F/DRILL CHUCK CLAM RANGE - Ø4

    MDR report key: 4200499 · Received October 24, 2014

    Report

    Report Number
    3009450871-2014-10530
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 10, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HTW
    PMA / PMN Number
    PN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE COMMON DEVICE NAME HAS BEEN UPDATED TO: SYNTHES, SPARE KEY F/DRILL CHUCK, CLAMPING RANGE Ø 4.0MM. DEVICE PRODUCT CODE: (B)(4) (GMDN). CORRECTION: THE PMA/510(K) NUMBER WAS CORRECTED FROM N/I (NO INFORMATION) TO N/A (NOT APPLICABLE). 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

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND NO FAILURES WERE IDENTIFIED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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 3 OF 4 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A SCAPHOTRAPEZIOTRAPEZOID (STT) ARTHRODESIS SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TRANSMISSION SHAFT OF THE ATTACHMENT DEVICE BROKE AND THE KIRSCHNER WIRE COULD NOT BE INSERTED INTO THE BONE. ACCORDING TO THE REPORTER, ANOTHER ATTACHMENT DEVICE WAS USED AND THE SAME ISSUE WAS OBSERVED. THE DEVICE WAS IN USE WITH RELATED KEY DEVICES. AS A RESULT, THERE WAS A THREE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SECOND SPARE DEVICE WAS AVAILABLE AND WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS 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
    678426 SPAREKEY F/DRILL CHUCK CLAM RANGE - Ø4 SYNTHES, SPARE KEY F/DRILL CHUCK, CLAMPING RANGE Ø 4.0MM HTW DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1