BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE

    MDR report key: 6600940 · Received May 31, 2017

    Report

    Report Number
    1719045-2017-10520
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 5, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART #: 04.037.231S, LOT#: 9902067 (STERILE) - 12 MM/125 DEG TI CANN TFNA 400 MM/LEFT - STERILE. QUANTITY 6. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION WAS MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.912.2 - LOCK PRONG 125 DEGREE, TFNA LOT - 9486523, 04.037.912.4 - WAVE SPRING, SHIM ENDED LOT - 7840792, 04.037.912.3 - TFNA LOCK DRIVE LOT - 9877240, 21127 - RAW MATERIAL LOT - 9854992. 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.¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 23-SEP-2015. EXPIRATION DATE: 30-SEP-2025. 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

    BASED ON THE X-RAY RECEIVED, WE CAN CONFIRM THAT THE NAIL IS BROKEN AS REPORTED. PRODUCT WAS NOT RETURNED AND, AN INVESTIGATION COULD NOT BE PERFORMED. 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. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 12 MM 125 DEGREE 400 MM LEFT TROCHANTERIC PROXIMAL FEMORAL NAIL ADVANCED (TFNA) ON (B)(6) 2016. THE TFNA NAIL BROKE ON (B)(6) 2017. PATIENT WAS REVISED TO A 14 MM 130 DEGREE 380 MM NAIL ON (B)(6) 2017. THIS REPORT IS FOR ONE (1) 12 MM TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE NAIL BROKE AT THE BLADE JUNCTION. CONCOMITANT DEVICE: TFNA HELICAL BLADE, PERFORATED, L 100MM (PART 04.038.400S, LOT H100829, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383491 12MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9902067

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention