BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6 COMP WIRE 10 THREAD/150 LENGTH

    MDR report key: 11671898 · Received April 15, 2021

    Report

    Report Number
    2939274-2021-01861
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWN
    UDI-DI
    10886982076281
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). EVENT YEAR IS REPORTED AS 2021; HOWEVER EXACT DATE OF EVENT IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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. 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COMPRESSION WIRES BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 1.6 COMP WIRE 10 THREAD/150 LENGTH. THIS REPORT IS 4 OF 4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570164 1.6 COMP WIRE 10 THREAD/150 LENGTH INSTRUMENT COMPRESSION HWN WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.211.410 10886982076281

    Patients

    Seq Age Sex Outcome Treatment
    1