BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM

    MDR report key: 8248047 · Received January 15, 2019

    Report

    Report Number
    2939274-2019-55843
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Report Date
    January 2, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587011875
    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. 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

    DEVICE HISTORY LOT PART # 03.503.071, SYNTHES LOT # U121536, SUPPLIER LOT # U121536, RELEASE TO WAREHOUSE DATE: 20 JUL 2010, SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. 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. INVESTIGATION SUMMARY FLOW: VISUAL (APPEARANCE NOT AS EXPECTED) AND DEVICE INTERACTION/FUNCTIONAL VISUAL INSPECTION: THE RETURNED DEVICE WAS EXAMINED, AND THE DISTAL TIP WAS FOUND TO BE STRIPPED. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. NO FURTHER VISUAL DEFECTS OR DEFICIENCIES WERE NOTED. FUNCTIONAL TEST: NO FUNCTIONAL TEST WAS ABLE TO BE COMPLETED AS THE MATING SCREWS IN QUESTION WERE NOT RETURNED. THE FAILURE MODE OF WILL NOT HOLD IS LIKELY THE RESULT OF THE DEFORMED DISTAL TIPS AS IDENTIFIED DURING THE VISUAL INSPECTION. CONCLUSION: AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN UNKNOWN DATE, DURING ROUTINE CHECKS, THAT THE TWO MATRIXMANDIBLE/THORAX SCREWDRIVER BLADES DO NOT RETAIN THE SCREWS THAT WERE A PART OF TITANIUM STERNAL PLATING SYSTEM FIELD EQUIPMENT SET. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41333 MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC U121536 10887587011875

    Patients

    Seq Age Sex Outcome Treatment
    1