BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8 COMP WIRE 10 THREAD/200 LENGTH

    MDR report key: 11702229 · Received April 21, 2021

    Report

    Report Number
    2939274-2021-02003
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 25, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWN
    UDI-DI
    10886982073396
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, FOUR OLIVE TIP WIRES BROKE, FOUR PLATE BENDERS WERE USED, AND CEMENT HAS STAINED THE BENDERS. DRILL BIT WAS USED OVER WIRE FOR A SCREW, AND DRILL BIT WAS BENT. SCREW CADDY MEASURING TAB BROKE OFF DURING SURGERY WHEN TRAY WAS DROPPED ON SCREW CADDY. THE SURGERY WAS DELAYED FOR FOUR (4) MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). UNKNOWN CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.8MM COMPRESSION WIRE 10MM THREAD/200MM LENGTH. THIS REPORT IS 3 OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597241 2.8 COMP WIRE 10 THREAD/200 LENGTH INSTRUMENT COMPRESSION HWN WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.118.010 10886982073396

    Patients

    Seq Age Sex Outcome Treatment
    1