BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER F/CLICKX LOCKCAP SELF-HOLD W/T

    MDR report key: 3190484 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-04108
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    July 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    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. (B)(6). AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATED THE FOLLOWING: THE INVESTIGATION CARRIED OUT ON THE SCREW DRIVER SHOWED THAT ONE OF THE LOCKING PINS HAS BROKEN OFF COMPLETELY. IT IS REASONABLY SUGGESTED THAT THE PIN WAS NOT PUT INTO THE SCREW OPENING CONSISTENTLY. IN ACCORDANCE WITH THE SURGICAL TECHNIQUE THE SCREW DRIVER IN QUESTION IS INTENDED TO CENTER THE SCREW CAP ON THE 3D HEAD AND SUBSEQUENTLY TO CLOSE IT ¿FINGER TIGHT¿. THE SCREW CAP HAS TO BE REMOVED WITH THE USE OF THE SCREW DRIVER 314.131. FURTHERMORE THE INVESTIGATION ON THE BASIS OF THE MATERIAL AND PRODUCTION DOCUMENTS HAD SHOWN THAT THE SCREW DRIVER COMPLIES ABSOLUTELY WITH THE SPECIFICATIONS. FURTHER, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED AND IT STATES THE FOLLOWING: THE INVESTIGATION ON THE BASIS OF THE MATERIAL AND PRODUCTION DOCUMENTS HAD SHOWN THAT THE SCREW DRIVER CONFORMS TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE SCREWDRIVER BROKE OFF WHILE PLACING IN THE SCREW CAP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290886 SCRDRIVER F/CLICKX LOCKCAP SELF-HOLD W/T HXX SYNTHES GMBH 1738153

    Patients

    Seq Age Sex Outcome Treatment
    1