BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 32MM

    MDR report key: 7717945 · Received July 25, 2018

    Report

    Report Number
    8030965-2018-55253
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTY
    UDI-DI
    07611819702516
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES: JDW, JDS, JDN, HSB. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, WHILE THE SURGEON WAS ATTEMPTING TO DRILL AT THE DISTAL POSITION OF THE 9MM PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL, THE DRILL BIT INTERFERED WITH THE NAIL. SURGEON REMOVED THE HAND PIECE FROM THE DRILL BIT AND STRUCK IT SLIGHTLY WITH A HAMMER. THE SURGEON THEN ATTEMPTED TO INSERT A 4.9MM LOCKING BOLT, BUT THE BOLT WENT OUT OF BOUNDS. SURGEON THEN ATTEMPTED TO DRILL MANUALLY BUT WAS NOT SUCCESSFUL. SURGERY WAS COMPLETED WITHOUT INSERTION OF THE BOLT. IT WAS NOTED THAT, BECAUSE OF THE SIZE OF THE NAIL, THE CLEARANCE BETWEEN THE BONE SURFACE AND THE NAIL WAS VERY THIN. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE FOR TROCHANTERIC FIXATION NAILS (03.010.405, LOT NUMBER UNKNOWN, QUANTITY 1), 125 DEGREE AIMING ARM FOR PFNA BLADE (03.010.406, QUANTITY 1), PROTECTION SLEEVE (356.831, LOT NUMBER UNKNOWN, QUANTITY 1), DRILL (356.828, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.9MM LOCKING BOLT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562433 4.9MM TI LOCKING BOLT 32MM PIN,FIXATION,SMOOTH HTY OBERDORF SYNTHES PRODUKTIONS GMBH 07611819702516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention