BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 6321987 · Received February 10, 2017

    Report

    Report Number
    1719045-2017-10094
    Event Type
    Injury
    Date Received
    February 10, 2017
    Report Date
    January 13, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH OF THE TWO 4.0 MM TITANIUM (TI) LOCKING SCREWS WERE THE ONES THAT BROKE. PART/LOT NUMBERS FOR ALL THE LOCKING INVOLVED PROVIDED: PART 04.005.428S (4.0 MM TI LOCKING SCREW W/T25 STARDRIVE 38 MM F/IM NAILS-STER), LOT H060192, QUANTITY 1, (B)(4). PART 04.005.420S (4.0 MM TI LOCKING SCREW W/T25 STARDRIVE 30 MM F/IM NAILS-STER), LOT 9963952, QUANTITY 1, (B)(4). PART 04.005.424S (4.0 MM TI LOCKING SCREW W/T25 STARDRIVE 34 MM F/IM NAILS-STER), LOT 9814324, QUANTITY 1, (B)(4). PART 04.005.422S (4.0 MM TI LOCKING SCREW W/T25 STARDRIVE 32 MM F/IM NAILS-STER), LOT 7939617, QUANTITY 1, (B)(4). PART OF DEVICE REMAINS IN THE PATIENT; DEVICE NOT CONSIDERED EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: PART NUMBER OF CONCOMITANT PLATE PROVIDED AS 4.005.346S; HOWEVER, BASED ON PROVIDED LOT NUMBER, PART NUMBER IS MOST LIKELY VP3022.09. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO DELAYED UNION OF A DISTAL TIBIA FRACTURE. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016 FOR A FRACTURE TIBIA (RIGHT SIDE). THE HARDWARE REMOVAL WAS DUE TO TWO (2) BROKEN UNKNOWN 4.0 MM TITANIUM (TI) LOCKING SCREWS. THE HARDWARE REMOVAL CONSISTED OF: ONE (1) 2.4 MM/2.0 MM LOCKING COMPRESSION (LC)-DYNAMIC COMPRESSION PLATE (DCP) FULLY INTACT, TWO (2) BROKEN UNKNOWN 4.0 MM TITANIUM (TI) LOCKING SCREWS (PARTIALLY REMOVED). THE SURGEON REMOVED PARTS OF THE TWO BROKEN UNKNOWN 4.0 MM TITANIUM (TI) LOCKING SCREWS AND THE OTHER PARTS OF THE TWO SCREWS REMAIN IN THE PATIENT. ONE (1) 9 MM TIBIAL NAIL-345 WAS NOT REMOVED AND WAS FULLY INTACT. THE PATIENT WAS REVISED BY USING THE PATIENT¿S AUTO GRAFT AS THE BONE GRAFT, AT THE POINT OF FRACTURE AND IMPLANTED WITH A ONE-THIRD TUBULAR PLATE WITH COLLAR 7-HOLES/85 MM AND SIX (6) UNKNOWN CORTICAL SCREWS. THE HARDWARE REMOVAL AND IMPLANTATION WENT FINE. THERE WAS NO SURGICAL TIME DELAY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS OUTCOME IS GOOD. CONCOMITANT DEVICES REPORTED: 9 MM TIBIAL NAIL-345 (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); AND CORTICAL SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 4); 2.4 MM/2.0 MM LOCKING COMPRESSION (LC)-DYNAMIC COMPRESSION PLATE (DCP) (PART 4.005.346S, LOT 5813345). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105711 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention FOUR UNKNOWN CORTICAL SCREWS| ONE PART 4.005.346S, LOT 5813345, PLATE| ONE UNKNOWN 9MM TIBIAL NAIL-345