BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI STERNAL LOCKING STRAIGHT PL/8 HOLES

    MDR report key: 13734796 · Received March 11, 2022

    Report

    Report Number
    2939274-2022-00842
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 10, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10887587055237
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: HWC AND JDQ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 (B)(6) 2022, DURING A PROCEDURE, THE PIN INSIDE THE CENTER OF THE PLATE BROKE INSIDE THE PLATE AS IT WAS UNDERGOING BENDING. THREE PLATES WERE AFFECTED ALL THE SAME PART. THE PROCEDURE WAS COMPLETED. ANOTHER VENDOR¿S STERNAL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT OUTCOME STATUS REPORTED. THIS REPORT INVOLVES ONE (1) PLATE. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973450 TI STERNAL LOCKING STRAIGHT PL/8 HOLES PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 460.045 10887587055237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STERNAL LOCK-PL 2.4 STRAIG 8HO TI| TI STERNAL LOCKING STRAIGHT PL/8 HOLES| UNK - BENDING INSTRUMENTS| UNK - STERNAL FIXATION