BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM

    MDR report key: 4230618 · Received November 6, 2014

    Report

    Report Number
    0008031020-2014-00537
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K113327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT HOFFMANN LRF APEX PIN ADAPTOR HAD A STRESS CRACK CORROSION ISSUE AFTER SURGERY CAN BE CONFIRMED. THE ROOT CAUSE OF THIS BREAKAGE HAS BEEN IDENTIFIED AS A DESIGN ISSUE (MATERIAL NOT RESISTANT ENOUGH TO CORROSION). THIS PROBLEM HAS BEEN IDENTIFIED DURING NC AND IS ADDRESSED BY A CAPA . A NEW MATERIAL WILL BE IMPLEMENTED AS SOON AS VALIDATED BY (B)(4). AS THIS BREAKAGE IS DUE TO A DESIGN ISSUE, A CREDIT NOTE WILL BE DONE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    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

    IT WAS REPORTED THAT PATIENT HAD LEFT TIBIA SURGERY. AFTER SURGERY, PATIENT WENT HOME AND APEX ADAPTOR CRACKED. PATIENT RETURNED TO CLINIC TO HAVE NEW ADAPTOR PUT IN. AFTER SECOND ADAPTOR WAS PUT IN, IT WAS REALIZED THAT BASE WAS SHEARED OFF. PATIENT WILL HAVE SECOND ADAPTOR REVISED ON (B)(6) 2014. THIS COMPLAINT IS REFERENCING THE CRACKED APEX ADAPTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD LEFT TIBIA SURGERY. AFTER SURGERY, PATIENT WENT HOME AND APEX ADAPTOR CRACKED. PATIENT RETURNED TO CLINIC TO HAVE NEW ADAPTOR PUT IN. AFTER SECOND ADAPTOR WAS PUT IN, IT WAS REALIZED THAT BASE WAS SHEARED OFF. PATIENT WILL HAVE SECOND ADAPTOR REVISED ON 10/20/2014. THIS COMPLAINT IS REFERENCING THE CRACKED APEX ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714667 APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER TRAUMA SELZACH R25479

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention