BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORCI SCRW 8MM X 20MM STRL

    MDR report key: 7163491 · Received January 4, 2018

    Report

    Report Number
    1219602-2018-00016
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 11, 2017
    Report Date
    March 16, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010485540
    PMA / PMN Number
    K032224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. CLINICAL DETAILS WERE PROVIDED CONFIRMING THE SURGEON USED A NOTCHED DILATOR TO PREPARE THE INSERTION SITE. PER THE DEVICE IFU 1061039 UNDER WARNING: THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION. IF HARD BONE IS ENCOUNTERED AS IN THIS CASE, THE BIORCI TAP SHOULD BE USED.

    Additional Manufacturer Narrative · 1

    VISUAL ASSESSMENT OF THE SCREW CONFIRMED THE REPORTED BREAKAGE. THE DISTAL THREADS HAVE BROKEN OFF AND WERE NOT RETURNED FOR EXAMINATION. DIMENSIONAL ASSESSMENT OF THE SCREWS MAJOR DIAMETER WAS FOUND TO MEET PRINT SPECIFICATION. CLINICAL DETAILS WERE PROVIDED CONFIRMING THE SURGEON USED A NOTCHED DILATOR TO PREPARE THE INSERTION SITE. PER THE DEVICE IFU UNDER WARNING: THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION. IF HARD BONE IS ENCOUNTERED AS IN THIS CASE, THE BIORCI TAP SHOULD BE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR USED THE GUIDES AND DRILL BITS, WHICH ARE NEEDED TO PLACE THE 8X20 SCREW, BUT AT THE MOMENT OF PLACING IT, IT WAS LOOSE AND THE GRAFT WAS LOOSED TOO, FOR THIS REASON, THEY DECIDED TO REMOVE IT IN ORDER TO PUT IT BACK AGAIN, BUT THE NOTICED THAT THE TIP WAS MISSING A PIECE. THEN, THEY PROCEEDED TO REMOVE WHAT WAS LEFT OF THE SCREW INSIDE THE PATIENT AND PLACE A 9X30 SCREW, WHICH WORKED PROPERLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8237 BIORCI SCRW 8MM X 20MM STRL SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 7207918 50671991 03596010485540

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR