BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER SHAFT T2 TIBIA 3,5 X 85 MM

    MDR report key: 3834369 · Received May 28, 2014

    Report

    Report Number
    0009610622-2014-00244
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES. THE INSTRUMENT RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE INSTRUMENT BROKE IN A FORCED BRITTLE FRACTURE DUE TO OVERLOAD. ACCORDING TO THE EVENT DESCRIPTION THE INSTRUMENT WAS USED FOR THE EXTENSION OF A DISTAL FEMORAL GROWING PROSTHESIS (FURTHER DETAILS WERE NOT AVAILABLE). FOR STRYKER KIEL HMRS THE EXTENSION OF THE PROSTHESIS PERFORMED IN 4 STEPS: ¿ UNLOCK ¿ SCREWDRIVER CAT# 0283-5000 (AF 2MMM) TO BE TURNED ANTI-CLOCKWISE ¿ EXTENSION ¿ SCREWDRIVER CAT# 1123-0002 (AF 3,5MM) TO BE TURNED ANTI-CLOCKWISE ¿ LOCK - SCREWDRIVER CAT# 0283-5000 (AF 2MMM) TO BE TURNED CLOCKWISE ¿ CONTROL ¿ SCREWDRIVER CAT# 1123-0002 (AF 3,5MM) TO BE PLACED AND HELD IN POSITION DURING CHECK OF THE LOCKING FUNCTION. THE RETURNED AND BROKEN SCREWDRIVER BIT CAT# 18060292 IS NOT INTENDED TO BE USED FOR THE EXTENSION OF A HMRS GROWING PROSTHESIS. THUS THE REPORTED EVENT IS REGARDED TO BE NON-INTENDED USE.

    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 THERE WAS AN ATTEMPT TO LENGTHEN A DISTAL FEMORAL GROWING PROSTHESIS. THE SCREWDRIVER BROKE DURING SURGERY. CAUSE SURGERY TO BE INCOMPLETE AND BE RESCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATTEMPT TO LENGTHEN A DISTAL FEMORAL GROWING PROSTHESIS. THE SCREWDRIVER BROKE DURING SURGERY. CAUSE SURGERY TO BE INCOMPLETE AND BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312737 SCREWDRIVER SHAFT T2 TIBIA 3,5 X 85 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K0C100C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention