BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 12805088 · Received November 12, 2021

    Report

    Report Number
    2939274-2021-06674
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Report Date
    October 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - SCREWS: LOCKING/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. 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 PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REVISION SURGERY FOR SCREW PROMINENCE AND POTENTIAL LOSS OF FIXATION ON (B)(6) 2021. DISTAL MOST LOCKING SCREW IN AN RFN ADVANCED BACKED OUT 2 MONTHS AFTER INSERTION. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAILS: RAFN (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1), UNK - SCREWS: NAIL DISTAL LOCKING (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN), UNK - END CAP (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) UNK - SCREWS: LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704768 UNK - SCREWS: LOCKING SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - END CAPS: RAFN| UNK - NAILS: RAFN| UNK - SCREWS: NAIL DISTAL LOCKING