BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15

    MDR report key: 8574874 · Received May 2, 2019

    Report

    Report Number
    2939274-2019-57793
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Report Date
    April 23, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982077523
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULATED STARDRIVE SCREWDRIVER (PART # 03.240.002, LOT # H082473, MFG # 09-AUG-2016) WAS RECEIVED WITH THE DISTAL TIP TWISTED. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT FEATURES ARE SIGNIFICANTLY DEFORMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT, PART # 03.240.002, SYNTHES LOT # H082473, SUPPLIER LOT # NA, RELEASE TO WAREHOUSE DATE: 09 AUG 2016, MANUFACTURED BY SYNTHES (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. 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 THE EVENING OF MARCH 12, 2019, THE SALES CONSULTANT CONTACTED FIELD STOCKING LOCATION TO SAY THAT THE CANNULATED STARDRIVE SCREWDRIVER SHAFT ON SET FE45498 WAS BENT. THE SET WAS TO BE USED IN SURGERY ON MARCH 13, 2019. THE REPLACEMENT SET WAS SENT PRIOR TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15 THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367366 CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15 SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.240.002 H082473 10886982077523

    Patients

    Seq Age Sex Outcome Treatment
    1