BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLOTTED MALLET

    MDR report key: 10992224 · Received December 11, 2020

    Report

    Report Number
    1818910-2020-26809
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 25, 2020
    Report Date
    November 25, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    GFJ
    UDI-DI
    10603295178439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE HEAD COMPONENT DOES NOT FIRMLY THREAD ONTO THE MALLET, HOWEVER, NO BREAKAGE OR MISSING MATERIAL WAS IDENTIFIED. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : PC-(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA. IT WAS REPORTED THAT DURING THE SURGERY, THE WHITE PLASTIC PART OF THE MALLET CAME OFF. THERE WAS NO HARMS TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457037 SLOTTED MALLET HIP INSTRUMENTS : IMPACTION INSTRUMENTS GFJ DEPUY ORTHOPAEDICS INC US 6020-17-000 AH037061 10603295178439

    Patients

    Seq Age Sex Outcome Treatment
    1