BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SURGICAL INC.

    MDR report key: 19243737 · Received May 3, 2024

    Report

    Report Number
    3007208013-2024-00016
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Report Date
    July 19, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    LRW
    UDI-DI
    00887482110782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING ADDITIONAL INFORMATION AND/OR RETURN OF THE REPORTED DEVICE TO COMPLETE THE EVALUATION.

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT WITH MISSING SCREWS AND ADDITIONAL ITEMS FROM THE SAME LOT WERE RETURNED TO THE SUPPLIER ON 6/4/2024. UPON THE SUPPLIER'S INVESTIGATION OF THE RETURNED DEVICES: DEVICE HISTORY RECORD (DHR) WAS RETRIEVED AND REVIEWED BY QA & RA DEPARTMENT AFTER GETTING COMPLAINT NOTIFICATION FROM SYMMETRY/ASPEN. ALL MANUFACTURING PROCESSES AND INTERMEDIATE INSPECTION WERE PERFORMED. THE NON-CONFORMING RETURNED INSTRUMENTS WERE PHYSICALLY EVALUATED AND 2 INSTRUMENTS OUT OF 15 INSTRUMENTS WERE FOUND UNSCREWED WHILE ONLY 1 INSTRUMENT OUT OF REMAINING 13 INSTRUMENTS WAS FOUND WITH LOOSE SCREW DURING SCREW TORQUE INSPECTION. MOREOVER, 12 INSTRUMENT'S SCREW TORQUE WAS CHECKED AND THEY WERE FOUND TO BE OK. AFTER REVIEW OF DEVICE HISTORY RECORD (DHR) AND EVALUATION OF NON-CONFORMING RETURNED INSTRUMENTS, THE POTENTIAL REASON WHICH COULD LEAD TO THIS NON-CONFORMITY APPEARS TO BE EXCESSIVE BELT GRINDING AT THE LOWER PART OF THE BOX LOCK AREA ON THE 2 UNSCREWED INSTRUMENTS LEAVING LESS SPACE FOR THREADS OF SCREW TO BE THREADED/GRIP PROPERLY. THE ROOT CAUSE IS DETERMINED TO BE MANUFACTURING ERROR. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES, "TWO OF THE SCISSORS HAD SCREWS FALL OUT DURING THE CASE. THEY HAD TO TAKE X-RAYS AND THANKFULLY NEITHER OF THE SCREWS ENDED UP IN THE PATIENT."

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES, "TWO OF THE SCISSORS HAD SCREWS FALL OUT DURING THE CASE. THEY HAD TO TAKE X-RAYS AND THANKFULLY NEITHER OF THE SCREWS ENDED UP IN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770842 SYMMETRY SURGICAL INC. SCISSORS LRW SYMMETRY SURGICAL INC. 60-1868 2312314 00887482110782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown