BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R2.0

    MDR report key: 3649447 · Received February 27, 2014

    Report

    Report Number
    0009610622-2014-00101
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE EVALUATION REVEALED THE DISTAL TARGET DEVICE (DTD) TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR APPROX. 3 YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. THE SHIFTED SPRING WASHERS CONTACTED THE PEEK MATERIAL DURING CLAMPING AND GOT JAMMED; THE CLAMP MECHANISM WAS BLOCKED. THESE BLOCKING CREATED HIGH PRESSURE FORCES TO THE PEEK MATERIAL OF THE CLAMPING MECHANISM AND THE MATERIAL CRACKED. FINALLY THE CRACKED PEEK MATERIAL BROKE DURING LOCKING THE DTD TO A TARGET DEVICE. THE BROKEN CLAMPING MECHANISM IS DESIGN RELATED. A CHANGE REQUEST WAS INITIATED TO ADDRESS SHIFTED SPRING WASHERS; THE WASHERS WERE REPLACED BY AN ELASTIC SPRING ELEMENT (NON-METALLIC). THE DESIGN CHANGE BECAME EFFECTIVE IN (B)(6) 2014 (COMPLAINED DTD WAS MANUFACTURED PRIOR TO DESIGN CHANGE). FURTHERMORE A CHANGE REQUEST WAS INITIATED TO IMPROVE THE CURVATURES OF THE PEEK MATERIAL. THE RADIUS WAS CHANGED FROM 1MM TO 2MM. THE CHANGE BECAME EFFECTIVE IN (B)(6) 2010 (COMPLAINED DTD WAS MANUFACTURED POST TO DESIGN CHANGE). A CAPA WAS INITIATED TO ADDRESS ROUGH SURFACES AROUND THE CURVATURES (MANUFACTURING RELATED). A TOOL OPTIMIZING WAS PERFORMED AT THE SUPPLIER IN (B)(6) 2011 (COMPLAINED DTD WAS MANUFACTURED PRIOR TO CAPA). NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    THE NURSE REPORTED TO OUR SALES REP THAT HE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS PROCEDURE, HE OBSERVED THAT THE SURGEON HAD PROBLEMS WITH THE DISTAL TARGET DEVICE. WHILE USING THE DEVICE, THE FIXATION BROKE AND A CRACK WAS NOTICED. THE SURGEON WENT AHEAD WITH FREEHAND TARGETING TO COMPLETE THE SURGERY SUCCESSFULLY. ALSO, THE PROCEDURE HAS BEEN PERFORMED AS SPECIFIED.

    Description of Event or Problem · 1

    THE NURSE REPORTED TO OUR SALES REP THAT HE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS PROCEDURE HE OBSERVED THAT THE SURGEON HAD PROBLEMS WITH THE DISTAL TARGET DEVICE. WHILE USING THE DEVICE THE FIXATION BROKE AND A CRACK WAS NOTICED. THE SURGEON WENT AHEAD WITH FREEHAND TARGETING TO COMPLETE THE SURGERY SUCCESSFULLY. ALSO, THE PROCEDURE HAS BEEN PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120814 DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R2.0 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL KP324833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other