BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 5908959 · Received August 26, 2016

    Report

    Report Number
    0001825034-2016-03367
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    July 29, 2016
    Report Date
    February 28, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03366 / 03367). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 31-301852 ARCOS 3.5MM HEX DRIVE ZB160309, 22-300920 ARCOS 20X190MM SPL TPR DIST HA TPR DIST HA 364250, 31-301303 ARCOS CON SZ C STD 60MM TRL 242320. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION FOUND THE TRIAL EXHIBITS SURFACE SCRATCHES ON THE TAPER AND NEAR THE THREADED SCREW HOLE. DAMAGE WAS OBSERVED ON THE 1ST THREAD CONSISTENT WITH CROSSTHREADING.DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    DURING A HIP ARTHROPLASTY, THE TRIAL BODY WOULD NOT UNSCREW FROM THE IMPLANTED DEFINITIVE DISTAL STEM. IN ORDER TO UNSCREW THE COMPONENTS, A SCREWDRIVER WAS USED; HOWEVER, THE SCREWDRIVER TIP FRACTURED. THE ATTACHED TRIAL AND DEFINITIVE COMPONENTS WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AFTER A TEN MINUTE DELAY.

    Description of Event or Problem · 1

    DURING A HIP ARTHROPLASTY, THE TRIAL BODY WOULD NOT UNSCREW FROM THE IMPLANTED DEFINITIVE DISTAL STEM. IN ORDER TO UNSCREW THE COMPONENTS, A SCREWDRIVER WAS USED; HOWEVER, THE SCREWDRIVER TIP FRACTURED. THE ATTACHED TRIAL AND DEFINITIVE COMPONENTS WERE REMOVED FROM THE PATIENT. THE DISTAL STEM WAS REUSED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560161 ARCOS 3.5MM HEX DRIVE PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A ZB160309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention