BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5 3-FLTD DRILL BIT QC/230/200 CALIB

    MDR report key: 16460917 · Received March 1, 2023

    Report

    Report Number
    8030965-2023-02482
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 8, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    10886982189431
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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. ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 (B)(6) 2023, AS PREVIOUSLY REPORTED, THE SURGEON AGAIN HAS COMPLAINED ABOUT THE REDUCTION FORCEPS BEING DULL. THE HOSPITAL HAS PREVIOUSLY BEEN ASKED TO REPLACE THE FULL FORCEPS, HOWEVER NOT ALL OF THEM HAVE BEEN REPLACED YET. ADDITIONALLY A 2.5 DRILL BIT WENT DULL AFTER DRILLING SEVERAL HOLES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.5 3-FLTD DRILL BIT QC/230/200 CALIB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892089 2.5 3-FLTD DRILL BIT QC/230/200 CALIB BIT, DRILL HTW SYNTHES GMBH 315.92 10886982189431

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male REDUCTION FORCEPS POINTS SPEED LOCK 205.