BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3222838 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04229
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 6611824 REVEALED THE HOLDING SLEEVE-LONG FOR MATRIX WAS MANUFACTURED BY AVALIGN-NEMCOMED, SUPPLIER LOT NUMBER 88912. NCR (B)(4) WAS WRITTEN AGAINST THE LOT FOR THE MAJOR AND MINOR THREAD DIAMETERS BEING OUT OF TOLERANCE. THE LOT WAS 100% INSPECTED FOR THESE FEATURES. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WAS ONE ISSUE DURING THE MANUFACTURE OF THE PRODUCT THAT COULD POSSIBLY CONTRIBUTE TO THIS COMPLAINT CONDITION. CHANGED MANUFACTURING LOCATION FROM (B)(4).

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE THREADS ON THE HOLDING SLEEVE IS PARTIALLY BROKEN OFF. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED BECAUSE THIS DEVICE WAS MANUFACTURED AT SUSA. CURRENT MANUFACTURER IS SUSA. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT AVALIGN TECHNOLOGIES ¿ NEMCOMED MANUFACTURED THE RETAINING SLEEVE FOR MATRIX, P/N 03.632.036, LOT NUMBER 6611824. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE FOR LOT NUMBER 6611824, INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.632.036, THE LOT WAS INSPECTED TO THE SYNTHES INSPECTION SHEET. DUE TO AN UNKNOWN CAUSE, THE M6.5X0.75-3H4H THREAD IS DAMAGED ON THE LEADING THREADS. THE SHAFT AREA EXHIBITS SCUFF MARKS AND SCRATCHES. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    DURING A LUMBAR FUSION WITH THE MATRIX PEDICLE SYSTEM ON AN UNKNOWN DATE, THE SCRUB TECH WAS LOADING A MATRIX SCREW WITH THE MATRIX SCREWDRIVER/HOLDING SLEEVE. THE THREADS ON THE HOLDING SLEEVE BECAME CROSS-THREADED, CAUSING THE THREADS TO BREAK. ALL BROKEN PARTS WERE RETRIEVED, AND ANOTHER HOLDING SLEEVE WAS SELECTED TO CONTINUE THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322415 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6611824

    Patients

    Seq Age Sex Outcome Treatment
    1