BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM/125 DEG TI CANN TFNA 340MM/LEFT - STERILE

    MDR report key: 7469719 · Received April 27, 2018

    Report

    Report Number
    8030965-2018-53422
    Event Type
    Injury
    Date Received
    April 27, 2018
    Report Date
    April 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    10886982097873
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICAL MANUFACTURE SITE 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

    ADDITIONAL NARRATIVE: PATIENT IDENTIFIER, AGE, DATE OF BIRTH, AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 16-JUN-2015 . EXPIRATION DATE: 30-JUN-2025 . PART #: 04.037.925S (EU ITEM), LOT#: 9828183 (STERILE) - 9MM/125 DEG TI CANN TFNA 340MM/LEFT- STERILE. QUANTITY (B)(4). INSPECTION SHEET FOR IN PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION MEET SPECIFICATION. COMPONENT PARTS REVIEWED: 04.037.912.2 - LOCK PRONG 125 DEGREE, TFNA BP-55 LOT ¿ 9345493 , 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7840773 , 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 7993634 , 21127 - RAW MATERIAL LOT BP-80 LOT ¿ 9805382. RAW MATERIAL FOR TI WAS RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST RECEIVED FROM (B)(4) FOR TITANIUM INGOT MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. 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.¿ 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 PATIENT WAS IMPLANTED WITH THE 9MM 125 DEGREE CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LONG NAIL FOR PROXIMAL FEMORAL SUBTROCHANTERIC FRACTURES ON (B)(6) 2016. ON UNKNOWN DATE, IT WAS DETERMINED THAT THE NAIL HAD BROKEN AROUND THE BUMP-CUT AREA OF THE BLADE INSERTION HOLE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE THE NAIL WAS EXCHANGED FOR A TFNA LONG NAIL. SURGERY WAS COMPLETED SUCCESSFULLY. SURGEON STATED THE CAUSE OF THE NAIL BREAKAGE MAY HAVE BEEN METAL FATIGUE DUE TO PSEUDARTHROSIS. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9MM 125 DEGREE CANNULATED TFNA NAIL 340MM-LEFT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311732 9MM/125 DEG TI CANN TFNA 340MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 04.037.925S 9828183 10886982097873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention