BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR-DRIVER-HEX Ø3 W/T-HANDLE

    MDR report key: 3192708 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03567
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    December 9, 2011
    Report Date
    December 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    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. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE CONDUCTED INVESTIGATION HAS CONFIRMED THAT THE TIP OF THE PRESENT INSTRUMENT IS TWISTED. THESE INSTRUMENTS UNDERGO A TORQUE TEST BEFORE LEAVING THE PLANT AND NO VISIBLE ABNORMALITY HAS BEEN DETECTED. THESE FINDINGS INDICATE THAT EXCESSIVE TORSIONAL FORCES ARE RESPONSIBLE FOR THIS DEFORMATION. THE ITEMS SUBJECT TO COMPLAINT HAVE BEEN PRODUCED ACCORDING TO THE SPECIFICATIONS; THERE IS NO PRODUCT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEXAGONAL TIP BROKE OFF DURING SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292731 SCR-DRIVER-HEX Ø3 W/T-HANDLE HXX SYNTHES GMBH 3589521

    Patients

    Seq Age Sex Outcome Treatment
    1