BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE

    MDR report key: 7189166 · Received January 15, 2018

    Report

    Report Number
    2939274-2018-50252
    Event Type
    Injury
    Date Received
    January 15, 2018
    Report Date
    December 18, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982083074
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). DATE OF NON-UNION IS NOT KNOWN. DATE OF IMPLANT REPORTED AS APPROXIMATELY ONE YEAR PRIOR TO REMOVAL. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW: (B)(4), MANUFACTURING DATE: 01-MAY-2014, EXPIRATION DATE: 31-MAR-2023. PART #: 04.003.860S, LOT#: 7671625 (STERILE) ¿ 15MM TI-LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT - STERILE. QUANTITY 6. INSPECTION SHEET FOR INSPECTION DIMENSIONAL & FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: PART 21069, LOT: 7506606 FOR TITANIUM RECEIVED FROM (B)(4). (B)(4) CERTIFICATE OF TEST FOR TITANIUM MEETS SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED DUE TO ATROPHIC NON-UNION OF A RIGHT FEMUR ON (B)(6) 2017. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE; IT IS BELIEVED TO BE ABOUT A YEAR AGO. REMOVED HARDWARE INCLUDED: ONE NAIL AND TWO RECON SCREWS -ALL INTACT. THE REMOVAL WAS COMPLETED WITHOUT INCIDENT. THE PATIENT WAS REVISED TO A LARGE FRAGMENT PLATE AND SCREWS. BONE ASPIRATE AUTOGRAFT WAS USED FOR THE NON-UNION. IT IS NOTED THAT THE PATIENT IS ON FOSAMAX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 15MM LATERAL ENTRY FEMORAL RECON NAIL-EX. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35108 15MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 04.003.860S 7671625 10886982083074

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention