BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM QUICK-CONNECT DI POLYAXIAL SCREWDRIVER

    MDR report key: 3011350 · Received March 19, 2013

    Report

    Report Number
    1526439-2013-14094
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    June 23, 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 EVALUATION.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED SCREWDRIVER AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. THE BROKEN TIP SECTION WAS NOT RETURNED WITH THE PART. SCANNING ELECTRON MICROSCOPY ANALYSIS FOUND EVIDENCE OF A TORSIONAL SHEAR QUASI-STATIC FAILURE STARTING AT THE HEX LOBES AND IS EXTENDED TO THE CENTER OF THE SHAFT AS WELL AS TORSIONAL-SHEAR MARKINGS AND PLASTIC DEFORMATION AT ONE OF THE HEX LOBES. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE. HOWEVER, A REVIEW OF COMPLAINT TRENDS FOUND (B)(6) HAS A HIGHER COMPLAINT RATE VERSUS THE UNITED STATES AND OTHER COUNTRIES WHICH SUGGESTS THAT THE THEIR RATE DRIVEN BY A TECHNIQUE RELATED ISSUE. A CAPA HAS BEEN OPENED TO DOCUMENT FURTHER INVESTIGATION AND CORRECTIVE ACTION ACTIVITIES REGARDING TIP BREAKAGE IN (B)(6). AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE DISTAL TIP OF THE SCREWDRIVER BROKE OFF IN A DI SCREW BEING INSERTED INTO THE PATIENT'S RIGHT PELVIS. TIP BREAKAGE OCCURRED APPROXIMATELY 10MM FROM THE SCREW'S FINAL DESIRED POSITION WHEN AN AUDIBLE CLICK WAS HEARD. THE SCREW WAS REMOVED AND AN ALTERNATE FIXATION DEVICE WAS IMPLANTED. THE DIFFICULTY RESULTED IN THE NEED TO MAKE TWO INCISIONS IN EACH SIDE OF THE ANTERIOR PELVIS AND A TWENTY MINUTE DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113267 EXPEDIUM QUICK-CONNECT DI POLYAXIAL SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE MI21887

    Patients

    Seq Age Sex Outcome Treatment
    1