BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1

    MDR report key: 6801784 · Received August 17, 2017

    Report

    Report Number
    1219602-2017-00956
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 24, 2017
    Report Date
    September 7, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    PMA / PMN Number
    K992396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - TWO 7207557 STERILE BIORCI HA 7X25MM SCREWS RETURNED. SIX RELATED SAME REPEAT FAILURES DURING ONE PROCEDURE. THERE ARE SIX COMPLAINTS; ONE FOR EACH SCREW: C-0153838 C-0154034 C-0154036 C-0154037 C-0154040 C-0154041. (I-0153284) TWO OF SIX IMPLANTS HAVE BEEN RETURNED, IDENTIFIED AS C-0153838; THE FIRST COMPLAINT NUMBER OPENED. DIMENSIONAL INSPECTION CONFIRMS THAT THOSE RETURNED ARE 7X25MM PRODUCTS. DETAILS SUBSEQUENTLY PROVIDED CONFIRM THAT OTHER SIZES WERE ALSO USED IN THE AFFILIATED COMPLAINTS. THE RETURNED IMPLANTS HAVE BEEN USED AND ARE DAMAGED. APPROXIMATELY 7 TO 10MM MATERIAL IS MISSING FROM THEM. THE THREADS AND DISTAL TIP HAVE BEEN CHEWED UP AND SEVERED. THE MISSING PIECES WERE NOT RETURNED. THE STAR HEX¿S ARE IN FAIR CONDITION. THE PRODUCT¿S IFU CLEARLY SPECIFIES: ¿IF USING A 7 X 25 MM SCREW WITH AN 8 MM HEAD, IT IS ESSENTIAL TO USE A STEPPED ROUTER DURING DRILLING IN ORDER TO PROVIDE AN ADEQUATE SPACE FOR BOTH THE HEAD OF THE SCREW AND THE GRAFT¿. THIS COUNTER BORE IS NECESSARY TO CREATE SPACE WHICH WILL ACCOMMODATE THE 8MM SCREW HEAD AND THE GRAFT. IF THERE IS NOT SUFFICIENT SPACE FOR THE HEAD AND GRAFT, FORCE THEN BECOMES A FACTOR FOR POTENTIAL FAILURE. THE PHYSICAL CONDITIONS OF THE RETURNS INDICATE DIFFICULTY WITH PROPER INSERTION. THE IFU ALSO SAYS: ¿EXCESSIVE FORCE SHOULD NOT BE PLACED ON THE DELIVERY INSTRUMENT¿ AND ¿THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION.¿ IT WAS SUBSEQUENTLY CONFIRMED THAT THE IFU RECOMMENDATIONS/WARNINGS WERE FOLLOWED. NO ROOT CAUSE RELATED TO THE MANUFACTURING OF THIS DEVICE CAN BE CONFIRMED. DEVICE EVALUATED BY THE MANUFACTURER. EVALUATION CODES UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    WHEN APPLYING THE SCREW AND STARTING TO SCREW IT IN THE TIBIA, IMMEDIATELY THE TIP OF THE SCREW BROKE. THIS WAS DONE 6 TIMES. A BACKUP DEVICE WAS READILY AVAILABLE. THERE WAS A DELAY OF LESS THEN 30 MINUTES. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582487 SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1 SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 50504711

    Patients

    Seq Age Sex Outcome Treatment
    1