BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPDM QUICK-CON SI POLY SCWDRVR

    MDR report key: 3122705 · Received May 21, 2013

    Report

    Report Number
    1526439-2013-17452
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 30, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE INSTRUMENT AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP, THE SECOND HALF OF THE TIP WAS NOT PROVIDED WITH THE PART. THIS DEVICE HAS BEEN IN THE FIELD FOR APPROXIMATELY 5 YEARS AND HAS SEEN MUCH USAGE AS NOTED BY THE NUMEROUS MARKINGS AND SCRATCHES ON THE DRIVER SHAFT. SCANNING ELECTRON MICROSCOPY (SEM) WAS PERFORMED ON THE FRACTURED SURFACE TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS OF THE PART. THIS ANALYSIS FOUND EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR FAILURE STARTING AT THE HEXLOBES AND IS EXTENDED TO THE CENTER OF THE SHAFT. NO OTHER MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DHR IDENTIFIED NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND 8 RELATED COMPLAINTS FOR ISSUES OF THIS NATURE. A REVIEW OF THE DFMEA DVA-100351-DRAD WAS CONDUCTED. IT WAS CONCLUDED BASED ON THE IDENTIFIED OCCURRENCE AND SEVERITY THAT THE RISK IS BROADLY ACCEPTABLE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BONE WAS VERY HARD AND DRIVER GAVE IN AFTER LONG WEAR AND TEAR. THE SALES REPRESENTATIVE WAS CONTACTED AND HE REPORTED THAT THE TIP OF THE DRIVER WAS BENT. HOWEVER, RECEIPT OF THE DRIVER ON (B)(6) 2013 FOUND THE TIP HAD BROKEN OFF FROM THE INSTRUMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224788 XPDM QUICK-CON SI POLY SCWDRVR SCREWDRIVER HXX DEPUY SYNTHES SPINE 0508MI

    Patients

    Seq Age Sex Outcome Treatment
    1