BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLOTTED MALLET

    MDR report key: 14317208 · Received May 7, 2022

    Report

    Report Number
    1818910-2022-08401
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 6, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    GFJ
    UDI-DI
    10603295178439
    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). 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 · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED, THE ALLEGATION. IT WAS FOUND, THAT THE THREAD OF THE CELCON CAP WAS STRIPPED. 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 PLASTIC CAP ON THE MALLET IS STRIPPED. IT WILL NOT STAY ON THE MALLET. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576541 SLOTTED MALLET HIP INSTRUMENTS : IMPACTION INSTRUMENTS GFJ DEPUY ORTHOPAEDICS INC US 6020-17-000 AW0699 10603295178439
    277705 SLOTTED MALLET HIP INSTRUMENTS : IMPACTION INSTRUMENTS GFJ DEPUY ORTHOPAEDICS INC US 6020-17-000 AW0699 10603295178439

    Patients

    Seq Age Sex Outcome Treatment
    1 Female