BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 8201879 · Received December 28, 2018

    Report

    Report Number
    2939274-2018-55616
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Report Date
    December 4, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 314.030, LOT: 9761312. MANUFACTURING LOCATION: HAEGENDORF, RELEASE TO WAREHOUSE DATE: JUN 03, 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. THE SHAFT WAS RECEIVED SEPARATE FROM THE CORTEX SCREW AND NO DAMAGE WAS NOTED ON THE DEVICE. THERE IS SOME MINOR WEAR MARKS FROM USE. THE RETURNED DEVICE WAS TESTED WITH THE RETURNED BROKEN CORTEX SCREW AND THE COMPLAINT CONDITION COULD NOT BE REPLICATED AS THE DEVICES WERE ABLE TO BE DISASSEMBLED WITHOUT ISSUES. THE SHAFT PERFORMED AS INTENDED. AS THE COMPLAINT CONDITION COULD NOT BE REPLICATED, THE COMPLAINT IS UNCONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED AS NO ISSUES WERE FOUND WITH THE SHAFT. 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

    REPORTER IS SYNTHES EMPLOYEE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE HAS BEEN 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 ONE (1) UNKNOWN BROKEN CORTEX SCREW WAS NOTED TO BE STUCK TO A SCREWDRIVER SHAFT. IT IS UNKNOWN IF THERE WAS PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043447 SMALL HEXAGONAL SCREWDRIVER SHAFT SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9761312 10886982188380

    Patients

    Seq Age Sex Outcome Treatment
    1