BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 ROD HOLDER

    MDR report key: 3931574 · Received July 14, 2014

    Report

    Report Number
    1526439-2014-11681
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIPER2 ROD HOLDER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE FRACTURE WAS LOCATED AT THE HOLDER¿S DISTAL TIP APPROXIMATELY 25MM FROM THE WORKING END. IT WAS ALSO NOTED THAT THE FRACTURE DID NOT OCCUR AT THE TIP WELD LOCATION. SCANNING ELECTRON MICROSCOPY (SEM) FOUND EVIDENCE OF A STATIC BRITTLE OVERLOAD FRACTURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE VIPER2 ROD HOLDER, ADVANCED WAS CONDUCTED ON THE SPECIFIC PRODUCT CODE FROM THIS COMPLAINT FILE AS THERE IS NO PRODUCT FAMILY FOR THIS DEVICE THAT EXHIBIT A SIMILAR FAILURE MODE IN SIMILAR CONDITIONS. THIS ANALYSIS FOUND NO EMERGING TRENDS THAT REQUIRE FURTHER ACTION. THE ROOT CAUSE OF THE VIPER2 ROD HOLDER¿S DISTAL TIP BECOMING BROKEN CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE OPTICAL IMAGE NOTED THAT THE FRACTURE LOCATION REVEALS LITTLE PLASTIC DEFORMATION ACROSS MOST OF THE FRACTURE TERMINATION SITE SURFACE, CONSISTENT WITH A STATIC BRITTLE OVERLOAD FAILURE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THE FRACTURE ANALYSIS REPORT AND THERE ARE NO SYSTEMIC TRENDS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AT THIS TIME IT IS NOT KNOWN IF THE VIPER2 ROD HOLDER WILL BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE SURGEON WAS INSERTING A CONCOMITANT DEVICE VIPER ROD USING THE VIPER2 ROD HOLDER AND HEARD A CRACK. HE LOOKED DOWN AND RECOGNIZED THERE WAS A CRACK IN THE ROD HOLDER. HE IMMEDIATELY PULLED OUT THE ROD HOLDER AND ROD FROM THE SURGICAL SITE AND USED THE OTHER VIPER2 ROD HOLDER THAT WAS CONTAINED IN THE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409869 VIPER2 ROD HOLDER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0408MI

    Patients

    Seq Age Sex Outcome Treatment
    1 VIPER ROD CATALOG # UNK