BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11082

    MDR report key: 3061839 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-11082
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURING EVALUATION FOR THE DEVICE(S) STATES: THIS FAILURE HAS NOT BEEN REPLICATED WITH THE UPDATED SPINDLE ASSEMBLY TO THIS HANDLE (REV E) BY PRODUCT DEVELOPMENT WHILE FOLLOWING PROPER TECHNIQUE DESCRIBED IN THE TECHNIQUE GUIDE AND TRAINING. THIS FAILURE MODE IS THE SUBJECT OF A CAPA. THE RETURNED SPINDLE ASSEMBLY COMPONENT OF THIS HANDLE IS NOT TO THE LATEST REV (REV E) AS INDICATED IN THE MANUFACTURING REVIEW. IT WAS NOT MADE WITH THE REVISED MATERIAL THAT WAS INCLUDED AND RELEASED WITH REV E TO HELP MITIGATE THIS FAILURE MODE AS PART OF THE CAPA. THE NEW SPINDLE ASSEMBLY HAS MULTIPLE DISTINGUISHING MARKS, INCLUDING THE SYNTHES LOGO ON THE KNOB AND A PART (03.802.151) AND LOT NUMBER ETCHED ON THE SHAFT. THESE MARKERS PROVIDE VISUAL CUES OF THE MATERIAL DESIGN CHANGE ON THE SPINDLE ASSEMBLY TO IMPROVE RESISTANCE TO BREAKAGE, AS PART OF THE RESOLUTION TO THE CAPA. THE COMPLAINT IS DEEMED VALID, BUT THIS ISSUE HAS BEEN CORRECTED THROUGH A CAPA. NO NEW CAPA REQUIRED. THE CURRENT RISK ASSESSMENT (REV F) COVERS THE FRACTURING OF THE TRIAL SPACER HANDLE SPINDLE ON LINE 1. THE SEVERITY (3) ASSOCIATED WITH AN ELONGATION OF SURGICAL TIME, AND OCCURRENCE (2) ARE APPROPRIATE FOR THIS COMPLAINT AND THE CLINICAL HISTORY TO DATE.

    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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L4-S1 AP FUSION, THE INNER SHAFT OF A SYNFIX HANDLE BROKE OFF INTO THE TRIAL SPACER. THE TRIAL WAS REMOVED. THE BROKEN PIECE FROM THE INNER SHAFT IS STILL STUCK IN THE TRIAL. PATIENT WAS NOT HARMED. EVENT #1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163924 LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1