BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - DRILL BITS: TRAUMA

    MDR report key: 9899698 · Received March 30, 2020

    Report

    Report Number
    2939274-2020-01607
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DRILL BITS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. 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, 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

    IT WAS REPORTED ON MARCH 9, 2020, DURING AN UNKNOWN PROCEDURE, WHILE THE SURGEON WAS USING THE AIMING ARM FOR SUPRAPATELLAR FOR PROXIMAL INTERLOCKS ON AN EXPERT TIBIAL NAIL, THE DRILL MISSED THE LOCKING HOLE THROUGH THE TARGETED GUIDE AND HIT THE NAIL. THE GUIDE AND DRILL WERE REMOVED BY UTILIZING THE PERFECT CIRCLES TECHNIQUE. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: CANN CONNECTIONS SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX(PART NUMBER 03.010.404, LOT U261953, QUANTITY 1), AIMING ARM FOR SUPRAPATELLAR (PART NUMBER 03.010.441, LOT 170039-202, QUANTITY 1), INSERTION HANDLE SUPRAPATELLAR (PART NUMBER 03.010.440, LOT 180183-101, QUANTITY 1), NAILS (UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1). THIS REPORT INVOLVES ONE (1) UNK - DRILL BITS: TRAUMA. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363446 UNK - DRILL BITS: TRAUMA BIT, DRILL HTW WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1