BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSP METATARSAL SHORTENING SYSTEM

    MDR report key: 10362300 · Received August 4, 2020

    Report

    Report Number
    3009540749-2020-00020
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    June 23, 2020
    Report Date
    August 4, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    LXH
    PMA / PMN Number
    K140714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS FOR THE PRODUCT WERE REVIEWED AND REVEALED NO MANUFACTURING DEFECTS. THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR REVIEW. IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2020 USING THE MSP METATARSAL SHORTENING SYSTEM, THE SCREWDRIVER TIP BROKE OFF INTO THE HEAD OF THE SCREW. DRIVER TIP WAS NOT REMOVED FROM THE SCREW HEAD AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829434 MSP METATARSAL SHORTENING SYSTEM SCREWDRIVER LXH NEXTREMITY SOLUTIONS 168401917B

    Patients

    Seq Age Sex Outcome Treatment
    1