BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCR BIORCI-HA 7X25 7MM HEAD STERILE

    MDR report key: 10341102 · Received July 29, 2020

    Report

    Report Number
    1219602-2020-01148
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    July 4, 2020
    Report Date
    September 1, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010459916
    PMA / PMN Number
    K032224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7207674 STERILE BIORCI HA SCREW USED IN TREATMENT, WAS RETURNED FOR EVALUATION. PRODUCT THREADS HAD BEEN TORN OR FRACTURED OFF THE PROXIMAL END. IT WAS PARTIAL PRODUCT RETURNED IN PIECES. THE DISTAL TIP WAS ABSENT. SCUFF MARKS WERE NOTED INSIDE THE HEXES. THE RETURNED PORTIONS INDICATE STRESS TORQUE WAS A FACTOR. THE PHYSICAL CONDITION INDICATES DIFFICULT INSERTION ATTEMPT WITH EXCESS FORCE PLACED UPON THE IMPLANTS. ADHERENCE TO THE IFU PREP AND USE IS ESSENTIAL FOR OPTIMUM SUCCESS OF THE PRODUCT. PER INSTRUCTIONS FOR USE (IFU) 1061039: THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION. IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW FOR THE LOT NUMBER REPORTED, INDICATED NO CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. INSTRUCTIONS FOR USE (IFU) CONTAINS RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. RISK MANAGEMENT FILES CONTAIN THE REPORTED FAILURE. VARIOUS QUALITY CHECKS ARE IN PLACE TO ENSURE THAT THE MATERIAL OF THE DEVICE MEETS REQUIREMENTS DEFINED AND VALIDATED IN THE DESIGN PROCESS. NO INDICATIONS FROM THE DEVICE SHOW CAUSE THAT THE MATERIAL WAS RELATED TO THE REPORTED FAILURE. NO ROOT CAUSE ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE WAS CONFIRMED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCL RECONSTRUCTION, TWO SCREWS WERE FOUND TO BE FRACTURED. BROKEN PIECES WERE REMOVED WITH TWEEZERS THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805337 SCR BIORCI-HA 7X25 7MM HEAD STERILE SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 7207674 50782496 03596010459916

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention