BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.5MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 19680268 · Received July 5, 2024

    Report

    Report Number
    8030965-2024-08279
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    10886982273994
    PMA / PMN Number
    K993335
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11: ADDITIONAL NARRATIVE: H3, H4, H6: 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 THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT HARDWARE REMOVAL AFTER RIGHT HUMERUS NON-UNION. DURING THE PROCEDURE, BONE HARVEST CLOGGED INTO THE ASSEMBLY. THE RAI 2 SHAFT WAS STUCK INSIDE THE ASSEMBLY; THE PLASTIC WAS CUT AWAY FORM THE SHAFT. THIS REPORT IS FOR AN RAI 2 REAMER HEAD. THIS IS REPORT 2 OF 5 FOR (B)(4). (B)(4) CAPTURES THE INTRA-OPERATIVE RAI 2 ISSUES. RELATED COMPLAINT (B)(4) CAPTURES THE REQUIRED REVISION PROCEDURE DUE TO NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448036 15.5MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO SYNTHES GMBH 10886982273994

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male 15.5MM REAMER HEAD FOR RIA 2 STERILE.| 16.5MM REAMER HEAD FOR RIA 2 STERILE.| RIA 2 BONE HARVESTING KIT 520MM STERILE.| RIA 2 REAMING KIT 520MM STERILE.