BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM

    MDR report key: 10456810 · Received August 26, 2020

    Report

    Report Number
    2939274-2020-03808
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 31, 2020
    Report Date
    July 31, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTW
    UDI-DI
    10886982075321
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE, SURGEON WAS PLATING THE THIRD MC HAND FRACTURE AND BROKE THE HEADS OFF OF THREE (3) 1.5MM VARIABLE ANGLE LOCKING SCREWS, AND ONE (1) 1.5MM CORTEX SCREW. THE HEADS WERE RETRIEVED BUT THE SCREW SHAFTS REMAINED IN THE PATIENT. THE SURGEON ALSO BROKE THE TIP OFF TWO (2) 1.1MM DRILL BITS. ONE (1) WAS RETRIEVED AND A 4MM LENGTH PIECE OF THE OTHER WAS LEFT IN THE PATIENT. THE SURGEON DETERMINED A STABLE FIXATION WITH THE SCREWS THAT WERE NOT BROKEN. A CIRCLAGE WIRE WAS PLACED AROUND THE PLATE BOTH PROXIMALLY AND DISTALLY. FRAGMENTS GENERATED FROM THE BROKEN SCREW SHAFTS AND A 4MM SEGMENT OF THE DRILL BIT WERE LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE13MM, 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE12MM, 1.5MM VA-LCK SCR SLF-TP W T4 STARDRIVE11MM, 1.5MM CRTX SCRW SLF-TP W T4 STARDR REC 11MM, 1.1MM DR BIT/STRYK J-LATCH F HL/65MM. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917761 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM BIT, DRILL HTW WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.130.201 10886982075321

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR