BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRUNS CURETTE 9 STR SIZE 2

    MDR report key: 17330114 · Received July 14, 2023

    Report

    Report Number
    3014334038-2023-00107
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    May 19, 2023
    Report Date
    September 5, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    LXH
    UDI-DI
    10381780187363
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BRUNS CURETTE 9 STR SIZE 2 (240124) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. THE ISSUE OF BREAKING MAY BE THE RESULT OF ROUGH HANDLING OR WEAR. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING CURETTAGE AND GRAFTING RIGHT PROXIMAL HUMERUS CYST, THE BRUNS CURETTE 9 STR SIZE 2 (240124) BROKE OFF IN A PATIENT INTRA-OPERATIVELY. IT WAS REPORTED THAT THE TIP COULD NOT BE RETRIEVED; HOWEVER, THERE HAS BEEN NO REPORTED POST-OPERATIVE COMPLICATIONS. NO INFORMATION HAS BEEN PROVIDED AS TO WHETHER THERE WAS SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767099 BRUNS CURETTE 9 STR SIZE 2 N/A LXH INTEGRA LIFESCIENCES MANSFIELD 10381780187363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown