BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULL REDUCTION INSTRUMENT FOR LISS

    MDR report key: 3192592 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04112
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION HAS BEEN CONDUCTED. CONSIDERING THE STRENGTH OF THE PLATE, IT IS NECESSARY THAT THE SURGEON ENSURE THE PULL REDUCTION DEVICE, INSERTION SLEEVE AND PLATE HOLE ARE PROPERLY ALIGNED WHEN PULLING THE BONE TO THE PLATE. FAILURE TO DO SO MAY RESULT IN EXCESSIVE STRESS AT THE PIN/BONE INTERFACE OF THE PULL REDUCTION DEVICE, LEADING TO POTENTIAL BREAKAGE OF THE PIN TIP. CONSIDERING THE RELATIVELY LOW FAILURE RATE OF THIS DEVICE, IT IS UNLIKELY THAT THE DESIGN PLAYED A CONTRIBUTING FACTOR IN THE DEVICE FAILURE. THE FAILURE IS MORE LIKELY RELATED TO TECHNIQUE ERROR WHEN APPLYING THE DEVICE OR OVER TORQUING THE NUT ON THE STABILIZATION BOLT. THIS COMPLAINT IS DETERMINED TO BE INVALID. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS CONDUCTED. THE DIAMETER OF THE REMAINING BROKEN OFF THREADED PORTION SB4X1 MEETS SPECIFICATION. THE SURFACE OF THE FRACTURED AREA IS HOMOGENEOUS AND DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE.

    Description of Event or Problem · 1

    DURING SURGERY FOR A DISTAL FEMUR FRACTURE ON (B)(6) 2013, WHILE THE SURGEON WAS USING THE INSERTION GUIDE FROM THE LESS INVASIVE STABILIZATION SYSTEM TO REDUCE THE FRACTURE, THE TIP BROKE OFF. SURGEON CHOOSE TO LEAVE THE INSTRUMENT FRAGMENT IN THE PATIENT'S BONE. IT WAS REPORTED THAT DUE TO THIS EVENT NO ADDITIONAL TIME WAS ADDED TO THE SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292437 PULL REDUCTION INSTRUMENT FOR LISS FZX SYNTHES GMBH 7747504

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR