BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8

    MDR report key: 8634004 · Received May 22, 2019

    Report

    Report Number
    2939274-2019-58219
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Report Date
    February 21, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982188939
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. BACKGROUND: IT WAS REPORTED ON AN UNKNOWN DATE, TWO (2) HOLDING SLEEVE FOR SCREWS STARDRIVE AND ONE (1) DEPTH GAUGE FOR SCREWS WERE RECEIVED AT BIO-ENGINEERING FROM THE PROCESSING DEPARTMENT WITH ISSUE REPORTED UNKNOWN. THESE DEVICES NEED TO BE SEND OUT FOR REPAIR/REPLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE HOLD-SL F/SCR Ø2.4 T8 F/SCR DRIVER SHAFTS (P/N: 314.468, LOT # 6093176) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS MISSING A SPRING. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED HOLDING SLEEVE: 314-468, REV. G/D. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE HAD AN UNKNOWN MALFUNCTION. THE REPAIR TECHNICIAN REPORTED THE DEVICE WAS MISSING A SPRING AND REQUIRED FURTHER REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. 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 FINALIZED SERVICE RECORD DOCUMENTING DISPOSITIONING OF THE DEVICE WILL BE ARCHIVED IN THE TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO MISSING COMPONENT. THE DEVICE RECEIVED IS MISSING SPRING. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE HOLD-SL F/SCR Ø2.4 T8 F/SCR DRIVER SHAFTS (P/N: 314.468, LOT # 6093176). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE IT AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL CAUSE COULD BE DUE TO DEVICE USE AND STERILIZATION. 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 · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 314.468, SYNTHES LOT # 6093176, SUPPLIER LOT # NA, RELEASE TO WAREHOUSE DATE: 05 MAR 2009, MANUFACTURED BY SYNTHES BRANDYWINE, 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. A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE EVALUATION: THE CUSTOMER REPORTED THE DEVICE HAD AN UNKNOWN MALFUNCTION. THE REPAIR TECHNICIAN REPORTED THE DEVICE WAS MISSING A SPRING AND REQUIRED FURTHER REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, TWO (2) HOLDING SLEEVE FOR SCREWS STARDRIVE AND ONE (1) DEPTH GAUGE FOR SCREWS WERE DISCOVERED DURING AN INSPECTION BEFORE GOING THROUGH STERILIZATION AND WAS RECEIVED AT BIO-ENGINEERING. THE DEVICES HAVE AN UNKNOWN ALLEGATIONS/MALFUNCTIONS. THESE DEVICES NEED TO BE SEND OUT FOR REPAIR/REPLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425592 HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8 GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.468 6093176 10886982188939

    Patients

    Seq Age Sex Outcome Treatment
    1