BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM UNIVERSAL DRILL GUIDE

    MDR report key: 9437897 · Received December 9, 2019

    Report

    Report Number
    2939274-2019-62562
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Report Date
    November 20, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982190857
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 · 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: PART: 323.460, LOT: 1951022, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: AUGUST 14, 2008. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION THE DEVICE WAS RECEIVED IN BROKEN CONDITION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE WELD BETWEEN THE HANDLE AND 4.5 MM DRILL SLEEVE BROKE. THE COMPRESSION SPRING, HEAD, AND 3.2 MM DRILL SLEEVE WERE RECEIVED IN FELL APART CONDITION/SEPARATED FROM HOUSING CASE. THE COMPLAINT IS CONFIRMED. NO OBVIOUS MATERIAL DEFECTS WERE NOTED AT THE FRACTURE SURFACES OF THE WELD UNDER 10X MAGNIFICATION. DIMENSIONAL INSPECTION DIMENSION MEASUREMENT OF THE BROKEN FEATURE OF THE WELD WAS NOT POSSIBLE DUE TO THE RECEIVED CONDITION OF THE FEATURE. CONCLUSION: THE COMPLAINT IS CONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS MORE LIKELY THAT UNINTENDED EXCESSIVE FORCES SUCH AS DEVICE BEING DROPPED DURING USAGE/HANDLING CONTRIBUTED TO THIS COMPLAINT CONDITION. DURING THIS INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    INITIAL REPORTER IS COMPANY REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 THAT IN THE STERILE PROCESSING DEPARTMENT, A UNIVERSAL DRILL GUIDE AND A T25 STARDRIVE SCREWDRIVER SHAFT WERE NOTED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234163 4.5MM UNIVERSAL DRILL GUIDE GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 323.46 1951022 10886982190857

    Patients

    Seq Age Sex Outcome Treatment
    1