BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER

    MDR report key: 7260237 · Received February 9, 2018

    Report

    Report Number
    2939274-2018-50575
    Event Type
    Injury
    Date Received
    February 9, 2018
    Report Date
    January 22, 2018
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982227850
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT DATE OF BIRTH, GENDER AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. ORIGINAL IMPLANT DATE IS UNKNOWN/ DEVICE IS NOT EXPECTED TO RETURN/ REPORTER TELEPHONE NUMBER NOT AVAILABLE. PART #: 456.419S, LOT#: 7823165 (STERILE) - 11 MM/130 DEG TI CANN TROCH FIXATION NAIL 380 MM/LEFT - STERILE. QUANTITY 6. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 21-OCT-2014 , EXPIRATION DATE: 30-SEP-2023. COMPONENT PARTS REVIEWED: 456.314.3 - TROCHANTERIC FIXATION NAIL LOCK DRIVER TFN, BP 55, LOT 7748583. THE 456.315.2 - TROCHANTERIC FIXATION NAIL LOCK 130 DEG LOCK PRONG TFN, BP 58, LOT 7797398. THE 21069 - RAW MATERIAL LOT BP-80 LOT - 7708358 FOR TITANIUM RECEIVED FROM SUPPLIER (B)(4). ATI ALLVAC CERTIFICATE OF TEST MEETS SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR INSPECT DIMENSIONAL 456ID410 REV: V, FINAL INSPECTION 456FI410 REV: J MEET INSPECTION ACCEPTANCE CRITERIA. 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. SCN NO: 10664, ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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 THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DUE TO A BROKEN TITANIUM TROCHANTERIC FIXATION NAIL (TFN) AND UNHEALED FRACTURE. THE NAIL BROKE AT THE JUNCTION OF THE HELICAL BLADE. PATIENT HAS COMORBIDITIES OF METASTATIC CANCER AND CHRONIC NICOTINE DEPENDENCE; THEREFORE, THE FRACTURE NEVER HEALED CAUSING THE TFN TO FAIL AND BREAK TWO (2) YEARS LATER. THE NAIL, HELICAL BLADE AND DISTAL LOCKING SCREW WERE REMOVED INTACT AND A NEW TFN NAIL WAS IMPLANTED. NO SURGICAL DELAY OR PATIENT HARM. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103869 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 456.419S 7823165 10886982227850

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention