BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5 3-FLTD DRILL BIT QC/230/200 CALIB

    MDR report key: 15165922 · Received August 4, 2022

    Report

    Report Number
    2939274-2022-03131
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 10, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTW
    UDI-DI
    10886982189431
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: TO BE RETURNED FOR COMPLAINANT PART IS NOT EXPECTED 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, WHILE DRILLING IN THE DISTAL HUMERUS, THE SURGEON BROKE OFF THE END OF THE 2.5 DRILL BIT. THE FRAGMENT REMAINED IN THE PATIENT. THE SURGEON ELECTED TO NOT ATTEMPT TO REMOVE THE DRILL. WHILE INSERTING A 3.5 CORTEX SCREW THROUGH THE SAME DRILL HOLE, THE NEAR PORTION OF THE SCREW BROKE. THE SCREW FRAGMENTS WERE REMOVED, AND A SHORTER SCREW WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES/OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 2.5 3-FLTD DRILL BIT QC/230/200 CALIB. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322428 2.5 3-FLTD DRILL BIT QC/230/200 CALIB BIT, DRILL HTW WRIGHTS LANE SYNTHES USA PRODUCTS LLC 315.92 10886982189431

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention