BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS

    MDR report key: 3080887 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10539
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THAT THE COLLET IN THE RECEIVED ASSEMBLY IS STUCK IN THE UP POSITION IN THE REDUCTION BODY PAST THE RIVET LOCATION. THE PART WILL NOT BREAK FREE. ALL THE DIMENSIONS RELATED TO THE AREA OF THE COMPLAINT COULD NOT BE EVALUATED DUE TO THE COLLET BEING SLOTTED AND THE ASSEMBLY RETURNED WITH THE COLLET FROZEN IN THE UPWARD POSITION PAST THE RIVETS; THEREFORE, THE COMPLAINT IS CONSIDERED INDETERMINATE. (B)(4).

    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

    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 INFORMATION: A PRODUCT DEVELOPMENT EVENT EVALUATION FOR THIS COMPLAINT FILE WAS PERFORMED AND IT WAS CONCLUDED THAT THE JAMMED COLLET WAS MOST LIKELY CAUSED BY EXCESSIVE IMPACTION OF THE HEAD BY THE SURGEON IN AN ATTEMPT TO SEAT THE HEAD ON THE BONE SCREW. THIS WAS CONFIRMED BY THE SALES CONSULTANT WHO WAS PRESENT IN THE CASE. THE REASON FOR APPLYING A HEAVY IMPACTION FORCE TO THE SCREW HEAD IS UNKNOWN. IT IS POSSIBLE THAT THERE WAS BONY ANATOMY BLOCKING THE PATH OF THE HEAD OF THE SCREW OR THAT THE SCREW WAS BURIED TOO LOW. A REAMER IS PROVIDED IN THE MATRIX SET TO ALLOW THE SURGEON TO CLEAR AN APPROPRIATE AREA FOR HEAD ATTACHMENT. SURGEON LED BIOSKILLS LABS INVOLVING THE USE OF POP-ON HEADS WERE ALSO CONDUCTED THROUGHOUT THE PRODUCT DEVELOPMENT PROCESS. DURING THESE ACTIVITIES, IMPACTION WAS NOT NECESSARY TO ATTACH THE HEAD TO THE BONE SCREW AND IMPACTION IS NOT DISCUSSED IN THE TECHNIQUE GUIDE. IT SHOULD ALSO BE NOTED THAT IF THE COLLET IS JAMMED INTO THE UP POSITION, IT WILL NOT ATTACH PROPERLY TO THE SCREW AS DESCRIBED IN THIS COMPLAINT BECAUSE THIS IS THE POP-ON/REMOVAL POSITION OF THE ASSEMBLY. IT IS NOTED AGAIN THAT THE ORIGINAL AWARENESS DATE FOR THIS REPORT IS 12/16/2011. THE PRODUCT DEVELOPMENT EVENT EVALUATION WAS CLOSED OUT ON 01/04/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE, SURGEON WAS USING TI POLYAXIAL REDUCTION HEAD (04.634.002) TO CONNECT TO BONE SCREW, WHEN THE COLLET INSIDE THE TI POLYAXIAL REDUCTION HEAD BROKE AT HEAD AND DID NOT FUNCTION PROPERLY. THE TI POLYAXIAL REDUCTION HEAD WOULD NOT ATTACH TO THE BONE SCREW. SURGEON WAS ABLE TO USE OTHER HEAD SCREW TO COMPLETE THE PROCEDURE WITH NO HARM TO PATIENT.THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181009 TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS NKB SYNTHES BRANDYWINE 6624726

    Patients

    Seq Age Sex Outcome Treatment
    1