BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE, STAPLE

    MDR report key: 7317137 · Received March 6, 2018

    Report

    Report Number
    2939274-2018-50898
    Event Type
    Injury
    Date Received
    March 6, 2018
    Report Date
    February 6, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A REVIEW OF THE PROVIDED WEIGHT BEARING X-RAY CAN CONFIRM THAT THERE IS A NONUNION, PROBABLY CAUSED BY WEIGHT BEARING ACTIVITIES AS REPORTED. NO DAMAGE OR ISSUES WITH THE STAPLES WERE IDENTIFIED FROM THE PROVIDED X-RAYS. FURTHER INVESTIGATION INCLUDING A DIMENSIONAL AND MATERIAL CHECK WERE UNABLE TO BE PERFORMED ON THIS DEVICE SINCE IT WAS NOT RETURNED FOR INVESTIGATION. DHR REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN AND THE DEVICE WAS NOT RETURNED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, DATE OF BIRTH, AND WEIGHT NOT AVAILABLE FOR REPORTING. UNKNOWN WHEN NON-UNION OCCURRED. THIS REPORT IS FOR AN UNKNOWN BME STABLE. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THE 510K UNAVAILABLE. DEVICE IS NOT SCHEDULED FOR EXPLANT. DEVICE IS NOT AVAILABLE FOR RETURN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A LEFT GREAT TOE INTERPHALANGEAL FUSION OR ARTHRODESIS WITH AN UNKNOWN AXIAL SCREW FIXATION. REPORTEDLY, THE PATIENT WAS NON-COMPLIANT POST-OPERATIVELY AND THE FIXATION WAS LOST AND THERE WAS A SUBSEQUENT DELAYED UNION. ON (B)(6) 2017 THE PATIENT UNDERWENT REMOVAL OF THE UNKNOWN AXIAL SCREW AND REFUSION USING UNKNOWN BIOMEDICAL ENTERPRISES, INC. (BME) STAPLES WITH BONE GRAFT OF UNDETERMINED TYPE. THE PATIENT WAS NON-COMPLIANT POST-OPERATIVELY AND A NON-UNION DEVELOPED. IT IS UNKNOWN IF THE PATIENT HAS ANY DISCOMFORT RELATED TO THE NONUNION OR IF A DEVICE MALFUNCTION OCCURRED. FURTHER TREATMENT IS EXPECTED, BUT NOT PLANNED AS OF YET. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN BME STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160170 BONE, STAPLE JDR WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention