BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 8932358 · Received August 26, 2019

    Report

    Report Number
    2939274-2019-60095
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 26, 2019
    Report Date
    July 30, 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
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DRIVING CAP/THREADED (PART # 03.010.523 LOT # 8953338)) WAS RECEIVED AT US CQ. THE THREADED DISTAL TIP BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. THE BROKEN OFF FRAGMENT WAS RETURNED LODGED INTO AN INSERTION HANDLE. 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 RETURNED COMPONENTS OF THE DEVICE. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. 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 AND WAS WITHIN SPECIFICATIONS PER RELEVANT DRAWINGS. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWING, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WAS REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. MANUFACTURING RECORD EVALUATION: THE DRIVING CAP/THREADED (PART # 03.010.523, LOT # 8953338) WAS MANUFACTURED AT THE (B)(4) SITE ON 19-AUG-2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELEVANT TO THE COMPLAINT CONDITION WERE IDENTIFIED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE DRIVING CAP/THREADED (PART # 03.010.523 LOT # 8953338) AS THE THREADED DISTAL TIP WAS BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. PER THE COMPLAINT DESCRIPTION, THE DEVICE LIKELY BROKE WHEN THE DEVICE ASSEMBLY FELL AND HIT THE FLOOR. DUE TO THE IMPACT, THE DRIVING CAPS DISTAL TIP BROKE OFF AND REMAINED LODGED IN THE INSERTION HANDLE. BASED ON THE INVESTIGATION FINDINGS PIE 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. SUSTAINING ENGINEERING TICKET 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART #: 03.010.523, LOT #: 8953338, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 19. AUG. 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE, IT IS RELATED TO INCOMPLETE DOCUMENTATION. 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. 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: 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, THE DRIVING CAP/THREADED AND INSERTION HANDLE FOR SUPRAPATELLAR WAS BROKEN. IT WASN¿T DURING SURGERY. IT HAPPENED WHEN THE INSTRUMENT FELL ON THE FLOOR. 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
    723136 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 8953338 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1