BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 10885578 · Received November 23, 2020

    Report

    Report Number
    2939274-2020-05270
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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 THAT ON (B)(6) 2020, DURING FIXATION OF OLECRANON, THE STARDRIVE SCREWDRIVER SHAFT T8 55MM AND TORQUE LIMITING ATTACHMENT WOULD NOT PROVIDE APPROPRIATE TIGHTENING FEEDBACK ON VARIABLE ANGLE LOCKING SCREWS. THE SURGEON USED NON TLA SCREWDRIVER FOR FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AS PLANNED. CONCOMITANT DEVICES REPORTED: TORQUE LIMITING ATTACHMENT 1.2NM (PART # 03.110.002, LOT # 1008217, QUANTITY 1), STARDRIVE SCREWDRIVER SHAFT T8 55MM (PART # 314.453, LOT # 3172926, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING SCREW. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348681 UNK - SCREWS: LOCKING SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR