BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    MDR report key: 3083160 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11129
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    June 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, THREADED SLEEVE BROKE OFF FROM THE AIMING GUIDE AND BECAME LODGED IN THE IMPLANT, RENDERING BOTH THE SLEEVE AND IMPLANT UNUSABLE. IT WAS ALSO NOTED DURING THE PLACEMENT OF THE SCREWS THAT THE ANGLED DRIVER WAS NOT PROPERLY ENGAGING THE SCREW. SURGEON USED A NEW IMPLANT AND A DIFFERENT SLEEVE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183390 TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN MAX SYNTHES GMBH 2813613

    Patients

    Seq Age Sex Outcome Treatment
    1