BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIX BLADE 75MM

    MDR report key: 15801496 · Received November 15, 2022

    Report

    Report Number
    8030965-2022-09844
    Event Type
    Injury
    Date Received
    November 15, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    10886982178169
    PMA / PMN Number
    K981757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: JDO. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. 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

    IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS SURGICAL SITE INFECTION POSTOPERATIVE COMPLICATIONS REPORTED. PATIENT STATUS/ OUTCOME? FRACTURE UNITED AFTER REVISION WITH ANTIBIOTIC COATED IMN. THIS REPORT IS FOR ONE (1) HELIX BLADE 75MM. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198774 HELIX BLADE 75MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 282.234 10886982178169

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Required Intervention 135 DEG LCP DHHS SIDEPL-STD BRL 4 H| 4.5MM CORTEX SCREW SELF-TAPPING 38MM| 4.5MM CORTEX SCREW SELF-TAPPING 40MM| 4.5MM CORTEX SCREW SELF-TAPPING 42MM