BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM VA LOCKING DOUBLE DRILL GUIDE/WITH CONE F/2.0 VAL PL

    MDR report key: 19374774 · Received May 22, 2024

    Report

    Report Number
    8030965-2024-06599
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819690820
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    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. D2: ADDITIONAL PRODUCT CODE: HXP D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: INITIAL REPORTER IS A DEPUY SYNTHES EMPLOYEE. 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 THE DRILL GUIDE WAS SLIGHTLY BENT SO THE DRILL BIT WOULDN'T SLIDE THROUGH PROPERLY; IT WAS MEETING RESISTANCE. A DIFFERENT DRILL GUIDE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCES. THIS REPORT IS FOR A DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750335 1.5MM VA LOCKING DOUBLE DRILL GUIDE/WITH CONE F/2.0 VAL PL GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 07611819690820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female CUTT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC| UNK - DRILL BITS: TRAUMA| UNK - PLATES: TRAUMA