BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR 5 L64 F/NAILS TAN LIGHT GREEN

    MDR report key: 9302969 · Received November 10, 2019

    Report

    Report Number
    8030965-2019-70142
    Event Type
    Injury
    Date Received
    November 10, 2019
    Report Date
    October 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819789944
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION (BROKEN) BASED ON THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE (INFORMATION OR/AND MATERIAL), THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT. PART: 04.005.554S. LOT: 9951101. MANUFACTURING SITE: SELZACH. SUPPLIER: IL-MEDTEC AG. RELEASE TO WAREHOUSE DATE: (B)(6) 2016. EXPIRY DATE: MAY 01, 2026. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY DHR REVIEW IS DONE FOR NON-STERILE PART: PART NUMBER: 04.005.554. FRANCHISE LOT NUMBER: 9925728 . MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: (B)(6) 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON-STERILE DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A BROKEN TFN-ADVANCED PROXIMAL FEMORAL NAIL WAS REMOVED FROM A PATIENT WITH NON-UNION OF PROXIMAL FEMUR FRACTURE. NAIL WAS IMPLANTED ON (B)(6) 2018. THE PATIENT WAS DISCHARGED FROM FRACTURE CLINIC EVEN THOUGH THERE WAS EVIDENCE OF NON-UNION OF THE FRACTURE, MONTHS AFTER THE PRIMARY OPERATION. THE PATIENT REPORTED TO SURGEON APPROXIMATELY IN (B)(6) 2019 WITH PAIN, WITH X-RAYS SHOWING A BROKEN NAIL AND TWO (2) BROKEN DISTAL SCREWS. THE BROKEN NAIL AND SCREWS WERE REMOVED, AND THE FRACTURE WAS REVISED WITH A DIFFERENT SYSTEM. CONCOMITANT PRODUCTS REPORTED: UNKNOWN TFNA HELICAL BLADE (PART # / LOT # / QUANTITY: UNKNOWN), UNKNOWN CABLE/WIRE (PART# / LOT# / QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 64MM F/IM NAIL-STER. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097312 LOCKSCR 5 L64 F/NAILS TAN LIGHT GREEN SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 9951101 07611819789944

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention UNK - CABLE/WIRE| UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE