BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FEM NAIL Ø10 R 130° L235 TIMO15

    MDR report key: 6800069 · Received August 17, 2017

    Report

    Report Number
    1719045-2017-10787
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    June 2, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S DATE OF BIRTH, GENDER AND WEIGHT IS NOT PROVIDED FOR REPORTING. UNKNOWN WHEN DEVICE MALFUNCTIONED. (B)(4). IMPLANTED IN THE BEGINNING OF (B)(6) 2017. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERAPY DATE IS THE BEGINNING OF (B)(6) 2017. REPORTER PHONE NUMBER IS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART #: 04.037.044S, LOT#: 9970394 (STERILE) - 10MM/130 DEG TI CANN TFNA 235MM / RIGHT - STERILE. QUANTITY 6: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13-JAN-2016, EXPIRATION DATE: 31-DEC-2025: INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT ¿ 9716620, PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 7921077, PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9926239, PART 21127 - RAW MATERIAL LOT BP-80 LOT - 9833144. RAW MATERIAL RECEIVED FROM SUPPLIER METALWERKS PMD, INC. CERTIFICATE OF ANALYSIS FOR TITANIUM, RECEIVED FROM METALWERKS PMD, INC. MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. NO NON CONFORMANCE REPORTS (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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THAT AT THE BEGINNING OF (B)(6) 2017 THE PATIENT HAD A SURGERY AND THE TRAUMA-TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS IMPLANTED. ON (B)(6) 2017 REVISION SURGERY WAS PERFORMED AS THE SPIRAL BLADE REACHED THE SUBCHONDRAL REGION AND AFTER REMOVAL OF THE ROD, IT WAS NOTICED THAT THE PAWL WAS DAMAGED. FOR THIS REASON THERE WAS NO PISTONING. DURING THE REVISION SURGERY AFTER THE STEM WAS REMOVED, IT WAS NOTICED THAT THE LOCKING MECHANISM OF THE NAIL WAS DAMAGED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THE SURGERY WAS NOT PROLONGED. CONCOMITANT DEVICES REPORTED: GUIDE WIRE Ø 3.2MM, L 400MM (PART # 357.399, LOT # 9882940, QUANTITY 2), LOCKING SCREW Ø 5.0MM, L 36MM (PART # 04.005.526S, LOT # 9905798, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEGREE TI CANNULATED TFNA. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580138 TFNA FEM NAIL Ø10 R 130° L235 TIMO15 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9970394

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention GUIDE WIRE (PART # 357.399, LOT # 9882940, QTY 2)| LOCKING SCREW (PART 04.005.526S, LOT 9905798, QTY1