BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 8707190 · Received June 18, 2019

    Report

    Report Number
    2939274-2019-58709
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    May 20, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982198983
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. UPDATED EVENT DESCRIPTION PROVIDED FOR REPORTING. A REVIEW OF THE DEVICE HISTORY RECORD . DEVICE HISTORY LOT PART# 393.10, LOT# 9150111, MANUFACTURING LOCATION: HAGENDORF, RELEASED TO WAREHOUSE DATE: 02 MARCH 2015. NO NCRS WERE GENERATED DURING PRODUCTION. MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY BACKGROUND IT WAS REPORTED THAT ON MAY 20, 2019, A UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. SERVICE & REPAIR EVALUATION THE CUSTOMER REPORTED THAT UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THAT THE TIP OF CHUCK IS DAMAGED WE DO NOT KEEP THIS CHUCK IN STOCK. PART WAS STUCK IN CHUCK AND THE TIP OF THE PART IS BROKEN OFF AND MISSING. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. FLOW : DAMAGE THE UNIVERSAL CHUCK WITH T-HANDLE AND UNKNOWN GUIDE WIRE WERE RECEIVED SEPARATE AT CQ. UPON INSPECTION, IT WAS NOTICED THAT TIP OF THE CHUCK WAS FOUND SLIGHTLY BROKEN OFF,. AND BROKEN PIECE WAS NOT RETURNED. THE COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION: IT WAS NOT PERFORMED DUE TO THE POST MANUFACTURING DAMAGE . DOCUMENT/SPECIFICATION REVIEW: MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BUT, IT IS POSSIBLE THAT ROUGH HANDLING OR EXCESSIVE FORCE WAS APPLIED DURING USE AND/OR PROCESSING COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. UPDATED EVENT DESCRIPTION PROVIDED FOR REPORTING. 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

    UPDATE: IT WAS REPORTED THAT ON (B)(6) 2019, A GUIDE WIRE WAS STUCK ON A UNIVERSAL CHUCK WITH T-HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Description of Event or Problem · 0

    7/16/2019: IT WAS REPORTED THAT ON (B)(6) 2019, A GUIDE WIRE WAS STUCK ON A UNIVERSAL CHUCK WITH T-HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. 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 ON (B)(6) 2019, A UNIVERSAL CHUCK WITH T-HANDLE WAS DISCOVERED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500039 UNIVERSAL CHUCK WITH T-HANDLE MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 393.10 9150111 10886982198983

    Patients

    Seq Age Sex Outcome Treatment
    1