BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION PLIERS FOR CLICK-X

    MDR report key: 3033222 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-10651
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    April 5, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND NOTHING WAS BROKEN ON THE RECEIVED PARTS. THE CLICK-X HEAD REMOVAL TOOL WAS RECEIVED WITHOUT THE OUTER SLEEVE; THEREFORE, THE ARTICLE AND LOT NUMBER ARE UNKNOWN. WITHOUT THE OUTER SLEEVE OF THIS TOOL, NO EVALUATION WAS POSSIBLE, AS ALL RELEVANT DATA IS MARKED ON THE SLEEVE AND A FUNCTION TEST CAN ONLY BE PERFORMED WITH THE SLEEVE. IT COULD NOT BE DETERMINED WHY THE IMMOBILIZER WAS STUCK IN THE HEAD. THIS COMPLAINT WAS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PROCEDURE, THE HEAD IMMOBILIZER WAS STUCK IN THE HEAD OF THE CLICK-X HEAD REMOVAL TOOL. CONSULTANT REMOVED THE CLICK-X HEAD REMOVAL TOOL FROM THE HEAD IMBOLIZER AND THE HEAD IMMOBILIZER BROKE AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135979 EXTRACTION PLIERS FOR CLICK-X FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1