BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT

    MDR report key: 3180867 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03747
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    March 26, 2012
    Report Date
    April 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE INVESTIGATION OF THE COMPLAINED SHAFT SHOWS FULL CONFORMITY TO THE SPECIFICATION. VISUAL AND FUNCTIONAL CONTROL WAS PERFORMED. THE SHAFT WAS ASSEMBLED IN A 90 DEGREE SCREWDRIVER AND SCREWS WERE INSERTED INTO A BONE BLOCK WITHOUT ANY DIFFICULTY. IT IS POSSIBLE THAT THE HOSPITAL MIGHT HAVE ASSEMBLED THE SHAFT INCORRECTLY. REVIEW OF THE MANUFACTURING AND MATERIAL DOCUMENTATION SHOW CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. ADDITIONAL DEVICE CODE: DZJ. (B)(4).

    Description of Event or Problem · 1

    THE SCREW DID NOT GO INTO THE BONE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280432 SHAFT DZI SYNTHES GMBH 8112183

    Patients

    Seq Age Sex Outcome Treatment
    1