BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR BIORCI-HA 7X30 7MM HEAD STERILE

    MDR report key: 6654293 · Received June 20, 2017

    Report

    Report Number
    1219602-2017-00627
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    May 23, 2017
    Report Date
    July 7, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    PMA / PMN Number
    K002274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - ONE SHELF CARTON, PATIENT LABELS (2) AND WHITE FOIL POUCH FOR A BIORCI-HA 7X30MM SCREW WERE RETURNED FOR EVALUATION. SCREW WAS NOT RETURNED PROHIBITING ANY VISUAL OR DIMENSIONAL EVALUATION. ALTHOUGH THE SCREW WAS NOT RETURNED CLINICAL DETAILS WERE PROVIDED CONFIRMING THAT NO STARTER WAS UTILIZED AND THAT A ¿BIOSURE SCREW DRIVER¿ WAS USED TO INSERT THE SCREW. PER THE DEVICE IFU 1061039 UNDER WARNINGS: THE STARTER MUST BE UTILIZED WITH THE BIORCI¿HA SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION¿. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION THE BODY OF THE ANCHOR FRACTURED. ALL PIECES WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE FOLLOWING A 10 MINUTE DELAY. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436264 SCR BIORCI-HA 7X30 7MM HEAD STERILE SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 50505383

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR