BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM

    MDR report key: 8210560 · Received January 2, 2019

    Report

    Report Number
    0009610622-2019-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 4, 2018
    Report Date
    February 22, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540592545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM WAS ALLEGED OF ISSUE (INSTRUMENTS - SILICON DAMAGE) COULD BE CONFIRMED, SINCE THE RETURNED DEVICE MATCHES THE REPORTED FAILURE MODE. THE RECEIVED SET SCREWDRIVER SHOW SIGNIFICANT TRACES OF INTENSE AND FREQUENT USE. THE BLUE SILICONE AT THE AREA OF THE FLEXIBLE SPIRAL IS PARTLY MISSING. HOWEVER, BASED ON THE CATALOG NO. 13200233 AND LOT NO. K260793 OF THE RETURNED PRODUCT, IT CAN BE DETERMINED THAT THE RETURNED SCREWDRIVER IS A NEW VERSION AND SILICONE COATING HAS BEEN APPLIED SUBSEQUENTLY BY THE USER. THIS IS ALSO INDICATED BY THE ALMOST WHITE COLOR OF THE COATING WHICH TOTALLY DIFFERS FROM THE ORIGINAL (BLUE COLOR). THE RETURNED PRODUCT WAS THUS REFURBISHED BY A NON- STRYKER FIRM. NO INDICATIONS OF MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE IFU INCLUDES THAT THE DESIGN OF THE INSTRUMENT MUST NOT BE MODIFIED IN ANY WAY. FURTHERMORE, THE REQUIREMENTS FOR PROPER REPROCESSING OF MEDICAL DEVICES ARE EXPLICITLY DESCRIBED IN THE BROCHURE ¿INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE¿ (L24002000). SINCE SEPTEMBER 2009, THE NEW GAMMA3 FLEXIBLE SET SCREWDRIVER IS AVAILABLE TO ALL MARKETS. THE VERSION WITH THE SILICONE COVER WAS PHASED OUT AFTER THE INTRODUCTION OF THE NEW VERSION. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS CONSIDERED NOT DEVICE RELATED (ORIGINAL DEVICE) AS THE ORIGINAL SET SCREWDRIVER HAD EVIDENTLY BEEN MODIFIED BY THE USER. DUE TO THE FACT THAT THE SUBJECT INSTRUMENT HAD BEEN MODIFIED BY THE USER, IT HAS TO BE ASCERTAINED THAT STRYKER IS NOT RESPONSIBLE FOR THE CONSEQUENCES OF THE MODIFICATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE SHEATHING ON THE FLEXIBLE PART CAME OFF. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 10MIN. NOT LONGER.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SHEATHING ON THE FLEXIBLE PART CAME OFF. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 10 MIN. NOT LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3926 SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K260793 04546540592545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other