BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE

    MDR report key: 10979383 · Received December 9, 2020

    Report

    Report Number
    2939274-2020-05526
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 12, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982187673
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 312.200, LOT: 2043423. MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: 22.OCTOBER 2002. 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) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE TRIPLE DRILL GUIDE HOLE WAS NOTICED TO BE DAMAGE. THE DAMAGE WAS DONE PRIOR TO THE CASE. THE WIRE WOULD NOT PASS THROUGH ONE OF THE GUIDES. THE TRIPLE DRILL GUIDE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN WIRE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440367 2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE GUIDE, SURGICAL, INSTRUMENT FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 312.20 2043423 10886982187673

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR