BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKG. 10MM X 28MM STRYKER BIOSTEON SCREW

    MDR report key: 9257535 · Received October 30, 2019

    Report

    Report Number
    0002936485-2019-00487
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 2, 2019
    Report Date
    March 6, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HWC
    UDI-DI
    15060155710300
    PMA / PMN Number
    K003641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: SCREW BROKE. ACCORDING TO BIOCOMPOSITES: "INVESTIGATION FINDINGS ARE: BIOCOMPOSITES HAVE REQUESTED ADDITIONAL INFORMATION ABOUT WHAT TYPE OF GRAFT WAS USED FOR THE ACL PROCEDURE. BONE TENDON BONE GRAFT WAS USED. THE TYPE OF GRAFT HAS DIFFERENT REQUIREMENTS FOR TUNNEL AND SCREW DIAMETER. FOR BTB FEMORAL FIXATION, SCREW SIZE IS RECOMMENDED TO BE 23MM IN LENGTH AND 1MM OR 2MM LESS THAN TUNNEL DIAMETER. SCREW BROKE AS THE SIZE WAS TOO LARGE FOR THE TAPPED DIAMETER. STRYKER HAVE SHIPPED THE DAMAGED SCREW TO BIOCOMPOSITES LTD AND CAN CONFIRM THE NATURE OF THE DAMAGE IS CAUSED BY THE ABOVE RATIONALE. THE SUSPECTED ROOT CAUSES ARE HUMAN ERROR - SCREW SIZE IS RECOMMENDED TO BE 23MM IN LENGTH AND 1MM OR 2MM LESS THAN TUNNEL DIAMETER. THE CORRECTIVE ACTION IFU TO BE READ PRIOR TO INSERTION. SURGERY WAS COMPLETED SUCCESSFULLY." MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW BROKE AND PIECES REMAINED IN THE JOINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE AND PIECES REMAINED IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049822 PKG. 10MM X 28MM STRYKER BIOSTEON SCREW SCREW, FIXATION, BONE HWC STRYKER ENDOSCOPY-SAN JOSE 234-010-167 BS190404 15060155710300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other