BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 70MM - STERILE

    MDR report key: 6777105 · Received August 9, 2017

    Report

    Report Number
    1719045-2017-10747
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 13, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID #(B)(6), WEIGHT NOT PROVIDED FOR REPORTING. OTHER UDI: UDI: (B)(4). ORIGINAL IMPLANT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERAPY DATE IS UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 16-SEP-2016, EXPIRATION DATE: 31-AUG-2026. PART #: 04.037.242S, LOT#: H187905 (STERILE) - 12MM/130 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - 9951150, PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - H045941, PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H153485, PART 21127 - RAW MATERIAL LOT BP-80 LOT - H089199. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FOR TITANIUM FROM (B)(4) MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. 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. (B)(4), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    REMOVE CURRENT EVENT DATE FROM INITIAL MW, ACTUAL EVENT DATE IS UNKNOWN. DEVICE 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 PATIENT UNDERWENT REMOVAL OF A SHORT TFNA NAIL AND TFNA HELICAL BLADE ON (B)(6) 2017 DUE TO HELICAL BLADE MIGRATION COMPLETELY OUT OF THE TFNA NAIL TOWARDS THE PELVIC REGION AND MIGRATION OF THE NAIL SUPERIORLY. THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A SHORT TFNA, HELICAL BLADE AND DISTAL LOCKING SCREW FOR TREATMENT OF A PERTROCHANTERIC HIP FRACTURE NON UNION ON AN UNKNOWN DATE. THE SHORT NAIL WAS USED BECAUSE THE PATIENT HAS A LONG STEM TOTAL KNEE ON THAT SIDE. ON (B)(6) 2017, THE SURGEON REMOVED THE DISTAL LOCKING SCREW INTACT FROM THE TFNA AND IMPLANTED A CURVED BROAD PLATE WITH SCREWS AND CABLES TO TREAT A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE THAT OCCURRED IN THE AREA BETWEEN THE KNEE IMPLANT AND TFNA. IN MID TO LATE (B)(6), PATIENT FOLLOW-UP REVEALED THE HELICAL BLADE IN THE NAIL WAS BEGINNING TO PENETRATE THE FEMORAL HEAD. PATIENT FOLLOW-UP ON (B)(6) 2017 REVEALED THE HELICAL BLADE HAD COMPLETELY MIGRATED OUT OF THE NAIL INTO THE PELVIC REGION. CT NOTED THE HELICAL BLADE WAS PUSHING ONTO THE BLADDER. CYSTOSCOPY ON (B)(6) 2017 REVEALED THE BLADDER WAS NOT PENETRATED BY THE HELICAL BLADE. AFTER THE NAIL AND HELICAL BLADE WERE REMOVED, A GIRDLESTONE PROCEDURE WAS PERFORMED, REMOVING THE FEMORAL HEAD, NECK AND PROXIMAL PART OF TROCHANTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME REPORTED AS FINE. THIS COMPLAINT INVOLVES TWO DEVICES. SEE LINKED COMPLAINT FOR (B)(6) 2017 REVISION. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559617 12MM/130 DEG TI CANN TFNA 70MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H187905

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LOCKING SCREW (PART #, LOT # UNK, QTY UNK.