BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR EXTRACTION SCREWDRIVER

    MDR report key: 8286369 · Received January 29, 2019

    Report

    Report Number
    2939274-2019-56116
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Report Date
    January 10, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034714578
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.613.004, LOT: 6625878. SUPPLIER: TELEFLEX MEDICAL, INC., RELEASE TO WAREHOUSE DATE: MAY 10, 2011. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 INNER SHAFT FOR EXTRACTION SCREWDRIVER (PART # 03.613.004, LOT # 6625878, MFG DATE 10-MAY-2011) WAS RECEIVED WITH THREADS ON THE DISTAL TIP OF THE SCREWDRIVER DAMAGED.THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION MET SPECIFICATIONS. RELEVANT DRAWINGS WERE REVIEWED. THE COMPLAINT CONDITION IS CONFIRMED AS THE INNER SHAFT FOR EXTRACTION SCREWDRIVER (PART # 03.613.004, LOT # 6625878) WAS RECEIVED WITH THE THREADS ON THE DISTAL TIP DAMAGED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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 · 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. LOT NUMBER: 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 · 0

    ADDITIONAL CONCOMITANT DEVICE: SCREW (PART/LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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 THAT DURING A ROUTINE INSPECTION ON (B)(6) 2019, A PLATE HOLDING DRILL GUIDE BROKE APART WHILE TESTING IT. THE SALES CONSULTANT STATED THAT THERE WAS NOT ANY FORCE APPLIED TO IT. THEY DO NOT KNOW IF IT SUSTAINED A BLOW AND JUST BARELY CLUNG TOGETHER UNTIL THAT MOMENT. THE SALES CONSULTANT SQUEEZED IT WHEN TESTING THE LOCK FUNCTION OF THIS INSTRUMENT. ALSO, IT WAS NOTICED THAT THE THREADS ON THE DISTAL END OF THE INNER SHAFT OF THE SCREW REMOVAL TOOL WERE DAMAGED. THE INNER SHAFT WOULD NOT SCREW INTO A SCREW. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: EXTRACTION SCREWDRIVER (PART # 352.311, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77897 INNER SHAFT FOR EXTRACTION SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6625878 10705034714578

    Patients

    Seq Age Sex Outcome Treatment
    1