BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 2.5MM HEXAGONAL SCREWDRIVER

    MDR report key: 4093732 · Received September 16, 2014

    Report

    Report Number
    2520274-2014-13682
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    (B)(4): REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CANNULATED HEXAGONAL SCREWDRIVER WAS RETURNED WITH THE COMPLAINT THAT ¿IT WAS IDENTIFIED THAT THERE WAS DRIED BLOOD AND BONE INSIDE THE CANNULA.¿ UPON RECEIPT OF THIS DEVICE IT WAS SEEN THAT THE CANULATION IS FREE OF FOREIGN MATERIAL (BLOOD/BONE) INSIDE THE CANNULA. USING THE NAKED EYE, THEN 10X LIGHTED MAGNIFICATION, NO SUBSTANCE OF ANY KIND WAS FOUND IN THE CANNULA OR ON ANY EXTERNAL SURFACE. IT IS NOTED THAT THE DEVICE WAS CLEANED BY THE CUSTOMER AND AGAIN IN THE DECONTAMINATION PROCESS AT DEPUY SYNTHES PRIOR TO ANALYSIS OF THE COMPLAINT DEVICE. THE DESIGN RECORDS WERE VIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE RISK ANALYSIS ADEQUATELY ADDRESSES THE COMPLAINT EVENT. 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 THE FACILITY RECEIVED AN EVALUATION SET ON (B)(6) 2014. ON (B)(6) 2014, IT WAS IDENTIFIED THAT THERE WAS DRIED BLOOD AND BONE INSIDE THE CANNULA. THE CASE WAS CANCELLED AND THE PARTS WERE CLEANED PRIOR TO RETURNING THE EVALUATION SET TO US. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573535 CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES USA 8831197

    Patients

    Seq Age Sex Outcome Treatment
    1