BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM UNIVERSAL DRILL GUIDE

    MDR report key: 10772324 · Received November 2, 2020

    Report

    Report Number
    8030965-2020-08492
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 8, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H6: DEVICE WAS RECEIVED AND INVESTIGATION NOT YET COMPLETED. THE DEVICE HISTORY LOT AS FOLLOWS:. DEVICE HISTORY LOT: PART: 323.260, LOT: 9133516, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: OCT. 31, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE SURGERY. BEFORE THE SURGERY, WHEN THE SURGEON CHECKED THE UNIVERSAL DRILL GUIDE, IT DIDN'T WORK PROPERLY. THE SURGEON TOOK APART THE DRILL GUIDE AND FOUND THAT THE SCREW IN THE DRILL GUIDE HAD BEEN BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROBLEM AND SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238021 2.7MM UNIVERSAL DRILL GUIDE GUIDE FZX SYNTHES GMBH 9133516

    Patients

    Seq Age Sex Outcome Treatment
    1