BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE, G3 PLUS GAMMA3

    MDR report key: 3200847 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00369
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION REVEALED THE TARGET DEVICE TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE CRACKED RIM IS A RESULT OF THE REPORTED HITTING WITH A MALLET DURING THE SURGERY. TO PREVENT HITTING THE TARGET DEVICE IS MARKED WITH THE PRINTING ¿DO NOT HIT!.¿ FURTHERMORE THE IFU AND CLEANING INSTRUCTIONS INSTRUCT THE USER THAT HITTING THE TARGET DEVICE IS NOT ALLOWED. THEREFORE THE CASE WAS CAUSED BY A MISUSE. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY A GAMMA NAIL PLUS 3 TARGETER BROKE WHEN REMOVING. SURGEON WAS HITTING WITH MALLET WHEN THE PART BROKE. CAUSED NO DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY A GAMMA NAIL PLUS 3 TARGETER BROKE WHEN REMOVING. SURGEON WAS HITTING WITH MALLET WHEN THE PART BROKE. CAUSED NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303343 TARGET DEVICE, G3 PLUS GAMMA3 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KME904397

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other