BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX PEDICSCR Ø6.2 CANN PREASSMBL L45

    MDR report key: 3193429 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04156
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 NO COMPLAINT RELATED ISSUES WERE FOUND. THE MEASUREABLE DIMENSIONS OF THE ITEMS SENT WERE EXAMINED AND VISUALLY INSPECTED. IT WAS DETERMINED THAT THESE ITEMS CONFORM TO THE DESIGNS AND SPECIFICATIONS. THE LOCKING CAP COULD NOT BE CLICKED OPEN. DUE TO A LACK OF CLINICAL DATA, THE EXACT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. SINCE THE 3D HEAD IS STRONGLY BENT IT IS POSSIBLE THAT THE ROD WAS IMPROPERLY POSITIONED THROUGH USE OF EXCESSIVE FORCE AND THEREBY COMPLETELY BENT THE 3D HEAD. THE VISUAL INVESTIGATION OF THE DAMAGED LOCKING CAP ALSO POINTS TO AN ERROR IN HANDLING. NO PRODUCT ERROR COULD BE DETERMINED. THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE. (B)(6).

    Description of Event or Problem · 1

    DURING THE PLACEMENT OF THE LAST LOCKING CAP IT WAS IMPOSSIBLE TO FIX IT ON THE SCREW HEAD. AFTER A FEW TRIES, THE DOCTOR DECIDED TO REPLACE THE SCREW AS THE HEAD WAS SPREAD UP. THIS IS 2 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291652 CLICKX PEDICSCR Ø6.2 CANN PREASSMBL L45 MNH SYNTHES GMBH 3294358

    Patients

    Seq Age Sex Outcome Treatment
    1