BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMIDFACE SCREWDRIVER BLD MQC/SELF-RETAINING/76MM

    MDR report key: 4741861 · Received May 1, 2015

    Report

    Report Number
    2530088-2015-10134
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Report Date
    April 6, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE TOP LEVEL DEVICE HISTORY RECORD (DHR) SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE COMPONENT PART, 03.503.203, LOT U120632: DHR SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE MATERIAL DHR SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IN SUMMARY, THE REVIEW OF THE DHRS, INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE MATERIAL, COMPONENTS AND /OR FINAL PRODUCT, AS APPLICABLE, MET INSPECTION RECORDS, CERTIFICATION TEST VALUES, AND ACCEPTANCE CRITERIA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER SD313.271, MATRIXMIDFACE SCREWDRIVER BLD MQC/SELF-RETAINING/76MM, LOT NUMBER 6409832). THE SUBJECT DEVICE WAS RECEIVED IN GOOD CONDITION. THERE WAS NO APPARENT DAMAGE TO THE TIP OF SHAFT OF THE DRIVER BLADE. UNDER 10X MAGNIFICATION, THERE WAS SOME APPARENT SIGN OF USAGE, SUCH AS SURFACE SCRATCHES ON THE DRIVER TIP. UPON REVIEW OF THE DESIGN HISTORY FILE, IT IS DETERMINED THAT THE DESIGN REQUIREMENTS OF THIS DRIVER BLADE ARE ACCEPTABLE FOR THE INTENDED USE. UPON SIMULATION IN A FOAM BLOCK USING THE RETURNED DEVICES, THE COMPLAINT COULD NOT BE REPLICATED. 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

    IT WAS REPORTED THAT THE SCREWDRIVER BLADES ARE BECOMING DULL OVER TIME. THE SCREWDRIVERS ARE NO LONGER PICKING UP AND/OR ARE STRIPPING THE SCREW HEADS. THE MALFUNCTIONS OCCURRED DURING SURGERY; HOWEVER, ADDITIONAL DEVICES WERE READILY AVAILABLE. THERE WERE NO DELAYS IN ANY SURGICAL PROCEDURES AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287204 MATRIXMIDFACE SCREWDRIVER BLD MQC/SELF-RETAINING/76MM SCREWDRIVERS HXX SYNTHES BRANDYWINE 6409832

    Patients

    Seq Age Sex Outcome Treatment
    1