BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC DISTRACTOR ASSEMBLY

    MDR report key: 3210232 · Received July 8, 2013

    Report

    Report Number
    1526439-2013-20633
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    VISUAL INSPECTION OF THE RETUNED PEDIATRIC DISTRACTOR ASSEMBLY [PRODUCT CODE: 6983-27-722, LOT NO: JC786201] NOTED THAT ONE OF THE DISTIL TIP¿S FEET HAD BECOME BROKEN. THE BROKEN DISTAL TIP¿S FOOT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE PEDIATRIC DISTRACTOR ASSEMBLY [PRODUCT CODE: 6983-27-722, LOT NO: JC786201] WAS CONDUCTED IDENTIFYING THAT A LOT QUANTITY OF 1 UNIT WAS RELEASED TO STOCK ON 5/8/12 WITH NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN CONTRIBUTED 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. THE ROOT CAUSE OF THE FRACTURED DISTAL TIP¿S FOOT CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE NOTED DAMAGE ON THE DISTAL TIP¿S FOOT SUGGESTS THAT IT HAS BEEN SUBJECTED TO AN UNANTICIPATED AXIAL STRESS RESULTING IN A FRACTURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE, AND THERE HAS BEEN NO SYSTEMATIC TREND, THIS FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN ON THE DISTAL END OF THE DISTRACTOR ASSEMBLY BROKE OFF AND THE INSTRUMENT BECAME BENT DURING USAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310047 PEDIATRIC DISTRACTOR ASSEMBLY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1