BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCR BIORCI-HA 7X20 7MM HEAD STERILE

    MDR report key: 14750796 · Received June 20, 2022

    Report

    Report Number
    1219602-2022-00898
    Event Type
    Injury
    Date Received
    June 20, 2022
    Date of Event
    May 29, 2022
    Report Date
    July 30, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010459909
    PMA / PMN Number
    K002274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. IT WAS DETERMINED THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE POLYMER FOUND THAT THE STORAGE REQUIREMENTS FOR THE MATERIAL ARE SPECIFIED, AND THE MATERIAL MUST COMPLY WITH PROVIDED PERCENTAGE COMPOSITION SPECIFICATIONS AS MEASURED BY ASH TEST. A REVIEW OF THE CUSTOMER PROVIDED IMAGES FINDS A BOX/INSERTS CONFIRMING PRODUCT IDENTITY. A SCREW WITH THE DISTAL END FRACTURED AWAY IN A PLASTIC BAG IS ON TOP OF THE PRODUCT INSERT. PER CASE DETAILS, THE BROKEN SCREW WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURIES OR ADVERSE CONSEQUENCES WERE REPORTED. SINCE NO PATIENT INJURIES ARE BEING REPORTED NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, EXCESSIVE TORQUE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OFF-AXIS INSERTION, IMPROPER PREPARATION OF THE INSERTION SITE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI HA SCREW BROKE WHILE DEPLOYMENT. THE PIECES WERE RETRIEVED WITH ARTHROSCOPY HHI INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396992 SCR BIORCI-HA 7X20 7MM HEAD STERILE SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 7207686 50954586 03596010459909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other