BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 6460719 · Received April 5, 2017

    Report

    Report Number
    1719045-2017-10285
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. UDI: (B)(4). DEVICE WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    PART #: 456.315S, LOT#: H242738 (STERILE) - 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM - STERILE. QUANTITY 6. MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 01-DEC-2016; EXPIRATION DATE: 31-OCT-2025; INSPECTION SHEET FOR INPROCESS/INSPECT DIMENSIONAL/FINAL, MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 456.314.3 - LOCK DRIVER TFN, BP-55 LOT - H129059; 456.315.2 - 130 DEGREE LOCK PRONG TFN BP-58 LOT - H201559; 21069 - RAW MATERIAL LOT BP-80 LOT - 9869610. 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.¿ 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE FOR INTERTROCHANTERIC HIP FRACTURE ON (B)(6) 2017. UPON INSERTION OF HELICAL BLADE THROUGH THE NAIL, IT WAS NOTICED THAT THE PLUNGER BUILT INTO THE NAIL WAS ADVANCED, PREVENTING THE HELICAL BLADE FROM PASSING THROUGH THE NAIL. THE SURGEON PULLED THE PLUNGER BACKED UP AND CONTINUED TO INSERT HELICAL BLADE BUT IT WOULD NOT ADVANCE. HE REPOSITIONED GUIDE WIRE AND ATTEMPTED ONE MORE TIME WITH SAME RESULTS, THE HELICAL BLADE WOULD NOT ADVANCE. IT WAS DETERMINED BEST TO REMOVE THE NAIL AND HELICAL BLADE THAT WAS NOT ADVANCING AND REPLACED IT WITH ANOTHER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A TIME DELAY OF 15 MINUTES BECAUSE OF THE ATTEMPTS, REMOVAL, REASSEMBLY AND REINSERTIONS. THERE WAS NO HARM TO PATIENT AND THE PATIENT OUTCOME IS NOT AVAILABLE. THIS REPORT IS FOR ONE (1) TROCHANTERIC FIXATION NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242221 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H242738

    Patients

    Seq Age Sex Outcome Treatment
    1