BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 9432023 · Received December 6, 2019

    Report

    Report Number
    2939274-2019-62535
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Report Date
    November 18, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    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

    PRODUCT COMPLAINT # (B)(4). 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, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 03.010.523, LOT: L200078, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 07 FEBRUARY 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET WAS FOUND UNSTERILE WITH THE BROKEN DRIVING CAP/THREADED PIECE IN THE STERILE PROCESSING DEPARTMENT (SPD). UPON PUTTING THE SET BACK TOGETHER, IT WAS NOTICED THAT THE PIECE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE DRIVING CAP/THREADED (PART # 03.010.523/ LOT # L200078) WAS RECEIVED AT US CQ. THE THREADED DISTAL TIP BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. THE DEVICE HAD SURFACE SCRATCHES ALONG THE SHAFT AND SEVERAL DENTS ON THE TOP OF THE PROXIMAL HEAD FROM HAMMER BLOWS. THESE COSMETIC ISSUES ARE CONSISTENT WITH NORMAL WEAR. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED OF A BROKEN DISTAL TIP DIMENSIONAL INSPECTION: DUE TO THE BREAK BEING SLIGHTLY OBLIQUE IN NATURE AND IT ONLY LEAVING THE MOST PROXIMAL THREAD, IT WAS NOT POSSIBLE TO OBTAIN AN ACCURATE MEASUREMENT OF THE MINOR/MAJOR DIAMETER OF THE THREADED TIP. THE DIAMETER OF THE GROVE JUST PROXIMAL TO THE BROKEN TIP AS WELL AS THE SHAFT DIAMETER WAS MEASURED INSTEAD. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WAS REVIEWED. CONNECTOR FOR INSERTION HANDLE SE_380067 REV L DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED DRIVING CAP/THREADED AS THE THREADED DISTAL TIP WAS BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE (OFF-AXIS OR EXCESSIVE HAMMER BLOWS BASED ON THE NUMEROUS DENTS ON THE PROXIMAL SURFACE). THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS PIE-1565883 HAS BEEN LAUNCHED TO ADDRESS THE IDENTIFIED ISSUE. THE NEED FOR FURTHER CORRECTIVE/PREVENTIVE ACTION WILL BE ASSESSED WITHIN THE PIE. FURTHER INVESTIGATION WILL NOT BE CONDUCTED IN THIS COMPLAINT AS IT WILL BE ADDRESSED WITHIN PIE-1565883. SUSTAINING ENGINEERING TICKET # 345154 AS ALSO BEEN OPENED TO ADDRESS THIS ISSUE. 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 · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET WAS FOUND UNSTERILE WITH THE BROKEN DRIVING CAP/THREADED PIECE IN THE STERILE PROCESSING DEPARTMENT (SPD). UPON PUTTING THE SET BACK TOGETHER, IT WAS NOTICED THAT THE PIECE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216056 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L200078 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1