BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM DRIVER STEM, FOOT

    MDR report key: 16660773 · Received April 1, 2023

    Report

    Report Number
    2027754-2023-00009
    Event Type
    Malfunction
    Date Received
    April 1, 2023
    Date of Event
    January 4, 2023
    Report Date
    June 4, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    LXH
    UDI-DI
    00845694041492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2023. THE DEVICE WAS RETURNED ALONG WITH THE BROKEN TIP. VISUAL INSPECTION OF THE DEVICE DID NOT REVEAL ANY SIGNS OF DAMAGE OR WEAR ALONG THE LENGTH OF THE DEVICE. THE TIP OF THE DEVICE WAS FRACTURED AND SHOWED SLIGHT DEFORMATION. THE DEVICE WAS MEASURED WITH THE RETURNED TIP AND MEASUREMENTS INDICATED THE LENGTH OF THE DEVICE MET THE SPECIFIED LENGTH OF THE DRIVER, INDICATING NO MATERIAL WAS MISSING FROM THE RETURNED DEVICE. THIS DEVICE IS REUSABLE, AND IT IS UNKNOWN HOW MANY TIMES IT HAS BEEN USED AND UNDER WHAT CONDITIONS. THE REPORTED EVENT STATED THE DRIVER TIP BROKE OFF IN THE SCREW WHEN LOCKING THE SCREW INTO THE PLATE. THE DEVICE TIP WAS FRACTURED AS RECEIVED. THEREFORE, IT IS POSSIBLE THE DRIVER BROKE DUE TO AN OVERSTRESS CONDITION IF TOO MUCH TORQUE WAS APPLIED TO THE DRIVER WHEN ENCOUNTERING RESISTANCE (E.G. DENSE BONE) OR OVERTIGHTENING OF THE SCREW. HOWEVER, DUE TO UNKNOWN SURGICAL CONDITIONS, BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DRIVER TIP BROKE IN SCREW WHEN LOCKING THE SCREW INTO THE PLATE WAS RECEIVED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE COMPLAINT DATABASE IDENTIFIED ONE (1) COMPLAINT FOR PART NUMBER 320-2408, WHICH WAS THE COMPLAINT IN THIS REPORT. THE DRIVER WAS MANUFACTURED IN 2018. THIS DEVICE IS REUSABLE, AND IT IS UNKNOWN HOW MANY TIMES IT HAS BEEN USED AND UNDER WHAT CONDITIONS. THE REPORTED EVENT STATED THE DRIVER TIP BROKE OFF IN THE SCREW WHEN LOCKING THE SCREW INTO THE PLATE, THEREFORE, IT IS POSSIBLE THE DRIVER BROKE DUE TO AN OVERSTRESS CONDITION IF TOO MUCH TORQUE WAS APPLIED TO THE DRIVER WHEN ENCOUNTERING RESISTANCE (E.G. DENSE BONE) OR OVERTIGHTENING OF THE SCREW. HOWEVER, DUE TO UNKNOWN SURGICAL CONDITIONS, BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING, AND A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE, THE SCREWDRIVER TIP BROKE OFF IN THE SCREW HEAD UPON LOCKING THE SCREW INTO THE PLATE. THE SCREWDRIVER TIP REMAINED IN THE SCREW THAT WAS IMPLANTED IN THE PATIENT. THEREFORE, THE FRAGMENT OF THE SCREWDRIVER TIP REMAINS IN THE PATIENT. IT WAS REPORTED "THERE WERE NO ISSUES FROM A SURGICAL POINT OF VIEW". NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED, AND THIS ISSUE DID NOT PROLONG THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380345 2.7MM DRIVER STEM, FOOT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH OSTEOMED, LLC 320-2408 1131243 00845694041492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown