BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM HOHMANN RETRACT 8 SHT NARROW TIP 160

    MDR report key: 15616206 · Received October 17, 2022

    Report

    Report Number
    8030965-2022-08264
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    GAD
    UDI-DI
    10886982202512
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THESE INSTRUMENTS BROKE BUT WE USED OTHER ONE. THE SURGERY WAS DONE WITH SIMILAR ONES. IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) SM HOHMANN RETRACT 8 SHT NARROW TIP 160 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2932949 SM HOHMANN RETRACT 8 SHT NARROW TIP 160 RETRACTOR GAD SYNTHES GMBH 399.19 10886982202512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SM HOHMANN RETRACT 8 SHT NARROW TIP 160| SM HOHMANN RETRACT 8 SHT NARROW TIP 160