BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE

    MDR report key: 6728395 · Received July 20, 2017

    Report

    Report Number
    1719045-2017-10668
    Event Type
    Injury
    Date Received
    July 20, 2017
    Report Date
    June 23, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION. CONCOMITANT DEVICES ADDED, (THERAPY DATE): UNKNOWN DATE IN (B)(6) 2017. 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

    (B)(6). (B)(4). (THERAPY DATE): UNKNOWN DATE IN (B)(6) 2017. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. STERILE PART 04.037.263S, LOT 9912250: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 07, 2015. EXPIRATION DATE: AUGUST 31, 2025. COMPONENT PARTS 04.037.942.2, LOT 9404269; 04.037.912.4, LOT 7840793; 04.037.912.3, LOT 9882447. INSPECTION SHEET MET INSPECTION ACCEPTANCE CRITERIA. NO NON-CONFORMANCE REPORTS RELEVANT TO THE COMPLAINT CONDITION 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

    UPDATE 08/15/2017. CONCOMITANT DEVICES REPORTED: TFNA SCREW 110MM (PART NUMBER: 04.038.110S, LOT NUMBER: UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS ORIGINALLY IMPLANTED WITH A TITANIUM TROCHANTERIC FIXATION NAIL (TFN) IN (B)(6) 2017. POSTOPERATIVELY, THE NAIL BROKE THROUGH THE CANNULATION FOR THE LAG SCREW. ON (B)(6) 2017, THE PATIENT WAS BROUGHT IN FOR REVISION SURGERY WHERE THE NAIL WAS EXTRACTED QUICKLY USING TITANIUM EXTRACTION HOOKS AND INSTRUMENTATION FOR TFN SET. THE SURGEON DID AN OSTEOTOMY TO CORRECT THE ORIGINAL REDUCTION AND THEN REDUCED THE FRACTURE. AFTERWARDS, REAMER / IRRIGATOR / ASPIRATOR (RIA) OR BONE GRAFTING WAS PERFORMED TO BACKFILL THE ORIGINAL TRACK OF THE LAG SCREW WITH NORIAN DRILL HOLE AND IMPLANTED THE PATIENT WITH A NEW 135 DEGREE TFN NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: INTERLOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509981 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9912250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN QUANTITY OF UNKNOWN INTERLOCKING SCREWS