BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING

    MDR report key: 8282823 · Received January 28, 2019

    Report

    Report Number
    2939274-2019-56100
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Report Date
    January 8, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982072993
    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 · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART: 03.114.002; SYNTHES LOT: 6161776; SUPPLIER LOT: NA; RELEASE TO WAREHOUSE DATE: AUGUST 27, 2009; MANUFACTURED BY SYNTHES (B)(4). NO NONCONFORMANCE REPORTS (NCRS) 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. FLOW: DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED) VISUAL INSPECTION: THE RETURNED DEVICE WAS EXAMINED AND WAS FOUND TO HAVE A STRIPPED DISTAL TIP. 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. CONCLUSION: AFTER A VISUAL INSPECTION PER GUIDANCE, 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 THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER SHAFT T4 AND STARDRIVE SCREWDRIVER SHAFT T4, SELF-RETAINING ARE NOT EFFECTIVELY DRIVING THE SCREWS IN. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75704 STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6161776 10886982072993

    Patients

    Seq Age Sex Outcome Treatment
    1