BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3MM FMSTK,L AGG,L

    MDR report key: 8522592 · Received April 17, 2019

    Report

    Report Number
    1045834-2019-53385
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 5, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBE
    UDI-DI
    00845384012511
    PMA / PMN Number
    K113476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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. UDI:(B)(4). CORRECTION: INCORRECT DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS INCORRECT IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED FROM 12/19/2018 TO 1/10/2019. DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW: DEVICE HISTORY REVIEW: THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. HOWEVER, A DEVICE HISTORY REVIEW WAS PERFORMED WHICH INDICATED THAT THERE WERE NO NON-CONFORMANCE'S OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED WHICH INDICATED THAT THERE WERE NO COMPLAINTS FILED AGAINST THE REPORTED LOT NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    THIS IS REPORT 3 OF 4 FOR THE SAME EVENT: IT WAS REPORTED BY THE SURGEON THAT DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR DEVICE STARTED HEATING UP WHILE BEING USED TOGETHER WITH THE ATTACHMENT AND CUTTER DEVICE. ACCORDING TO THE SURGEON, THE STAFF REPLACED THE FIRST CUTTER DEVICE WITH A SECOND SIMILAR CUTTER. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE STOPPED AND WAS REPLACED WITH A SECOND SIMILAR DEVICE. THE PROCEDURE CONTINUED. THE SURGEON STATED THAT IT WAS DETERMINED LATER IN THE CASE THAT THE PATIENT RECEIVED A BURN AT THE WOUND SITE, SUGGESTING THE MOTOR DEVICE HEATING UP MAY HAVE CAUSED THE EVENT. IT WAS REPORTED THAT THE SURGEON DID USE ELECTRO CAUTERY ON HIS PROCEDURES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THERE WAS NO ADDITIONAL TREATMENT PERFORMED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AS PLANNED. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS NO PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316919 3MM FMSTK,L AGG,L DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES PRODUCTS LLC M453134249 00845384012511

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention MOTOR DEVICES, ATTACHMENT DEVICE, CUTTER DEVICE| MOTOR DEVICES, ATTACHMENT DEVICE, CUTTER DEVICE