BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH CAP INSERTER, SHORT

    MDR report key: 3243253 · Received July 23, 2013

    Report

    Report Number
    1526439-2013-21922
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. REVIEW OF COMPLAINTS FOUND NO EMERGING TRENDS. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THAT ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED IF THE COMPLAINT PRODUCT BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE REOPENED AND THE PRODUCT EVALUATED. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE MONARCH CAP INSERTER AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE OCCURRED AT THE DISTAL TIP OF THE INSTRUMENT. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED DURING EVALUATION OF PRODUCT. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS NOTED THAT THE FRACTURED SURFACES EXHIBITED GRAINY/ROUGH REGIONS WHICH ARE INDICATIVE OF STATIC FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THE ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT DURING EXTENSION OF POSTERIOR LUMBAR FUSION PROCEDURE, THE TIP OF THE FIRST CAP INSERTER BROKE WHILE REMOVING A LOCKING CAP FROM A MONARCH SCREW THAT WAS ALREADY IN PLACE. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THE PROCEDURE CONTINUED WITH AN ALTERNATIVE CAP INSERTER. HOWEVER, THE SECOND CAP INSERTER ALSO BROKE AT ITS TIP DURING INSERTION OF A LOCKING CAP. THE FRAGMENT FELL INTO THE SURGICAL SITE AND WAS REMOVED BY THE SURGEON. A THIRD CAP INSERTER WAS USED WITHOUT ISSUE. THE DIFFICULTIES RESULTED IN A DELAY OF APPROXIMATELY FIVE MINUTES TO THE PROCEDURE. THIS MEDWATCH REPORT IS BEING FILED FOR THE FIRST CAP INSERTER. SEE MFG MEDWATCH REPORT NO. 1526437-2013-21923 FOR THE SECOND CAP INSERTER THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343910 MONARCH CAP INSERTER, SHORT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE T0307

    Patients

    Seq Age Sex Outcome Treatment
    1