BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP 0DEG RT CUT BLK

    MDR report key: 13710451 · Received March 9, 2022

    Report

    Report Number
    1818910-2022-04292
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 9, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    HTZ
    UDI-DI
    10603295225287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR EXAMINATION. VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE ALLEGATION. THE DRILL IS STUCK AT THE CUTTING BLOCK. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED SINCE A VALID FINISHED GOOD LOT NUMBER WAS NOT PROVIDED FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL BIT BECAME BOUND UP AND STUCK IN THE TIBIAL CUTTING BLOCK. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855105 SIGMA HP 0DEG RT CUT BLK CUTTING BLOCK HTZ DEPUY INTERNATIONAL LTD - 8010379 9505-01-223 J0808 10603295225287

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown