BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 11579148 · Received March 27, 2021

    Report

    Report Number
    2939274-2021-01548
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    February 27, 2021
    Report Date
    February 27, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982198983
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: DURING EXTRACTION OF THE FRN NAIL THE TWO (2) UNIVERSAL CHUCK WITH T-HANDLE WERE BROKEN DUE TO FORCEFUL EXTRACTION. THE REPAIR TECHNICIAN REPORTED THE DEVICE HANDLE IS BENT. BENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: T-HANDLE. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 393.100. LOT: L621261. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 17.OCTOBER 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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) 2021, DURING FEMORAL RECON NAIL (FRN) INSERTION, THE FRN NAIL BECAME STUCK IN THE CANAL REQUIRING FORCEFUL IMPACTION AND SUBSEQUENT EXTRACTION. THE DRIVING CAP/THREADED BROKE OFF. DURING THE EXTRACTION OF THE FRN NAIL, THE TWO (2) UNIVERSAL CHUCK WITH T-HANDLE BROKE DUE TO FORCEFUL EXTRACTION. ACTION TAKEN WHEN THE EVENT OCCURRED WAS EXTRACTION OF NAIL, NEW REAM ROD INSERTED AND SAME FRN NAIL WAS INSERTED INTO FEMUR. THERE WAS SIXTY (60) MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476295 UNIVERSAL CHUCK WITH T-HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 393.10 L621261 10886982198983

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR