BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPAL TUNNEL ECTR BLADE ASSEMBLY

    MDR report key: 14920258 · Received July 5, 2022

    Report

    Report Number
    2134070-2022-00012
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 5, 2022
    Manufacturer
    STERILMED, INC.
    Product Code
    LXH
    UDI-DI
    10888551001953
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4). MANUFACTURE REPORT NUMBERS 2134070-2022-00011 ARE RELATED TO THE SAME EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE BLADES WERE REPORTED TO BE DULL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619643 CARPAL TUNNEL ECTR BLADE ASSEMBLY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STERILMED, INC. MIC81010 10888551001953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown