BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX DISTRACTOR RACK

    MDR report key: 3070214 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-11015
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    June 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION VISUAL INSPECTION REVEALED THE SCREW HAD SHEARED OFF THE THUMB SCREW ASSEMBLY. THE INSTRUMENT CORRESPONDS TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. A PRODUCT EVALUATION CONDUCTED TO INCREASE THE STRENGTH OF THE SCREW FOUND THAT THE SCREW WAS BEING OVER TIGHTENED DURING ASSEMBLY AND CRACKING THE SCREW. THE MANUFACTURING LOCATION HAS SINCE PROVIDED ASSEMBLERS A SPECIAL TOOL TO LIMIT THE TORQUE APPLIED TO THE RETAINING SCREW TO PREVENT FRACTURE. BASED ON THE INVESTIGATION THE COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    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

    CONSULTANT REPORTS: FOLLOWING THE CONCLUSION OF L4-S1 POSTERIOR FUSION PROCEDURE, THE MATRIX DISTRACTOR RACK BROKE. THE ARM WITH THE DISTRACTOR WING-NUT BROKE WHEN BEING REMOVED FROM THE SURGICAL SITE. THE WING-NUT CANNOT BE THREADED BACK ON. NOTHING BROKE INTO THE WOUND, NOTHING TO RETRIEVE. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172288 MATRIX DISTRACTOR RACK LXH SYNTHES GMBH T956354

    Patients

    Seq Age Sex Outcome Treatment
    1