BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLOTTED MALLET

    MDR report key: 10567245 · Received September 22, 2020

    Report

    Report Number
    1818910-2020-20648
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 8, 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 AND REVIEW OF THE PROVIDED PHOTOS CONFIRMED THE REPORTED EVENT. 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 # (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. H10 ADDITIONAL NARRATIVE: ADDED: D4 (LOT #), D10 AND H4 CORRECTED: H3 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

    (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 SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS REPORTED THAT THE DEVICE (P/N:242122000 OR P/N: 602017000)¿S PLASTIC TOP HEAD PART CAME OFF. THERE WAS NO INTERFERENCE FOR THE SURGERY AND NO HARM TO THE PATIENT. THE HOSPITAL STAFF TOLD THAT IT SEEMED THAT THE DEVICE¿S PLASTIC PART STRIPPED AND CAME OFF EASILY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032709 SLOTTED MALLET HIP INSTRUMENTS : IMPACTION INSTRUMENTS GFJ DEPUY ORTHOPAEDICS INC US 6020-17-000 AH037061 10603295178439

    Patients

    Seq Age Sex Outcome Treatment
    1