BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR Ø1.6

    MDR report key: 3183136 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03612
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    January 16, 2012
    Report Date
    April 5, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE EVALUATION REVEALED THAT THE WELD ON THE CONNECTION BETWEEN THE PIN AND THE WIRE IS BROKEN ON BOTH OF THE COMPLAINED TROCARS IS INDEED BROKEN OFF. THE INSTRUMENT MEETS FULLY TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. WE DO SUPPOSE THAT TOO MUCH MECHANICAL FORCE DURING THE PROCEDURE MAY HAVE CAUSED THE BREAKAGE OF THE WELD. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SCREWING THE TROCAR INTO THE TROCAR HOLDER THERE WAS A BREAKAGE AT THE JUNCTION OF THE SHAFT AND THE TIP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283057 TROCAR Ø1.6 HWJ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1