BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT PLATING SYSTEM

    MDR report key: 7175882 · Received January 9, 2018

    Report

    Report Number
    2027754-2016-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    June 21, 2016
    Report Date
    September 1, 2016
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    PMA / PMN Number
    K091614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS INCIDENT APPEARS TO BE ATTRIBUTED TO AN UNUSUAL PATIENT CHARACTERISTIC OF DENSE BONE. THE BREAKS IN THE 3 RETURNED SCREWS, A 2.7MM X 18MM STANDARD SCREW (P/N 321-2718), A 2.7MM X 14MM LOCKING SCREW (P/N 322-2714), AND A FPS 2.7MM X 16MM LOCKING SCREW (P/N 322-2716), ARE CONSISTENT WITH A TORQUE INDUCED BREAK. IT IS THE CONCLUSION OF THIS INVESTIGATION THAT THE UNUSUALLY HIGH DENSITY OF THIS BONE EXERTED SUFFICIENT RESISTANCE THAT CAUSED THE SCREWS TO BREAK WHEN THE SURGEON APPLIED TORQUE TO THEM DURING IMPLANTATION. THE FACT THAT THE SCREWS EACH BROKE AT DIFFERENT LOCATIONS ALONG THEIR SHAFTS SUPPORTS THE DENSE BONE DEDUCTION WHICH WAS SHOWN IN THE EVALUATION. THE LOT NUMBERS WERE NOT PROVIDED. THEREFORE, A REVIEW OF THE DHRS COULD NOT BE PERFORMED. THE REVIEW OF COMPLAINTS AND NCRS DID NOT IDENTIFY A SIMILAR ISSUE FOR THESE DEVICES. THE FOOT PLATING SYSTEM PRODUCT INFORMATION AND INSTRUCTIONS FOR USE GUIDE INCLUDES A WARNING THAT THE USE OF SCREWS IN HIGHLY DENSE BONE MAY LEAD TO IMPLANT FRACTURE OR FAILURE UPON INSERTION. THE RISK OF THE SCREWS BREAKING DURING INSERTION IS ALSO ASSESSED IN THE FPS FAILURE MODE AND EFFECTS ANALYSIS DOCUMENT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PHYSICIAN PERFORMED A LAPIDUS FUSION ON A PATIENT. ON (B)(6) 2016, THE PATIENT CONTACTED OSTEOMED TO NOTIFY US THAT SCREWS IMPLANTED IN HER LEFT FOOT HAVE BROKEN. WE RECEIVED CONFIRMATION THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. ALL OF THE HARDWARE WAS REMOVED, WITH THE EXCEPTION OF BROKEN SCREWS THAT WERE TOO DEEPLY IMBEDED. CROSSING 4.0 HEADLESS COMPRESSION SCREWS WERE USED TO FUSE THE JOINT. AFTER PLACING THE SCREWS, HE BACKFILLED THE SCREW HOLES WITH 3CC OSTEOVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20112 FOOT PLATING SYSTEM FOOT PLATING SYSTEM HRS OSTEOMED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention