BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3012532 · Received March 20, 2013

    Report

    Report Number
    1719045-2013-10394
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)

    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 SYNTHES DEVICE HISTORY RECORDS REVEALED THE LOCKING HOLDING SLEEVE - STANDARD FOR MATRIX WAS MANUFACTURED BY RMS COMPANY. ALL PARTS WERE MADE TO THE CORRECT REQUIREMENTS AND MET THE REQUIRED SPECIFICATIONS. THE DEVICE WAS RECEIVED AND THE THREADED END OF THE INSTRUMENT WAS BROKEN, BUT NOT COMPLETELY SEPARATED FROM THE INSTRUMENT. ALL PIECES WERE STILL ATTACHED TO THE INSTRUMENT. A DESIGN EVALUATION WAS PERFORMED AS PART OF THE PRODUCT DEVELOPMENT EVALUATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND THE THREADED END OF THE INSTRUMENT WAS OBSERVED TO HAVE BROKEN OFF AT APPROXIMATELY THE FIRST FULL THREAD. THE INSTRUMENT MAY NOT HAVE BEEN TIGHTENED PROPERLY, OR EXCESSIVE LATERAL FORCE MAY HAVE BEEN USED DURING SCREW INSERTION, OR A COMBINATION OF BOTH MAY HAVE CAUSED THE FAILURE. THE TECHNIQUE GUIDE EXPLAINS HOW TO LOAD THE SCREW PROPERLY ONTO THE HOLDING SLEEVE. IT IS UNKNOWN IF THE SURGEON WAS APPLYING EXCESSIVE LATERAL FORCE DURING SCREW INSERTION. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE AT L4-S1, THE THREADS ON THE TIP OF THE HOLDING SLEEVE BROKE OFF DURING SCREW INSERTION. THE THREADS WERE RETRIEVED FROM THE PATIENT. THE SCREW WAS FULLY INSERTED AND WAS LEFT IN PLACE. THE SURGEON HAD ANOTHER SCREWDRIVER TO USE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115939 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6633546

    Patients

    Seq Age Sex Outcome Treatment
    1