BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM

    MDR report key: 8689118 · Received June 11, 2019

    Report

    Report Number
    2939274-2019-58599
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Report Date
    May 28, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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

    CONCOMITANT DEVICE: MULITLOC HUMERAL NAIL (PART/LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS A SYNTHES SALES CONSULTANT 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 · 1

    IT WAS REPORTED ON (B)(6) 2019 DURING AN INSPECTION AT STERILE PROCESSING DEPARTMENT, THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AIMING ARM KNOB, THREE (3) DRILL SLEEVE AND THREE (3) PROTECTION SLEEVE OF THE MULTILOC HUMERAL NAIL INSTRUMENTS DID NOT ACCURATELY TARGET HOLES IN NAIL WITH DRILL BITS. THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL DEVICES FOR THIS EVENT ARE CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480865 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM BIT GFG WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAILS: MULTILOC HUMERAL