BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 3075355 · Received April 24, 2013

    Report

    Report Number
    2530088-2013-00713
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE DHR INDICATES THAT VENDOR DATA FOR G4 TRUE POSITION OF .0019 INCHES MAX. IS OVERSIZE TO .0180 INCHES. ALSO VENDOR DATA FOR C1 .0118-.0276 INCHES IS UNDERSIZE TO .011 INCHES. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE RETURNED AIMING ARM PART 357.366, LOT 3240024 WAS MANUFACTURED IN SEPTEMBER 2009 AND IS OVER 3 YEARS OLD. THE RETURNED BLADE GUIDE SLEEVE PART 357.369, LOT 4764115 WAS MANUFACTURED IN JUNE 2004 AND IS OVER 8 YEARS OLD. DURING THIS EVALUATION, THE RETURNED AIMING ARM AND BLADE GUIDE SLEEVE FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE FUNCTION OF THE RETURNED DEVICES. THE CONSTRUCT ASSEMBLED AND THE RETURNED DEVICES ALIGNED AND ENGAGED AND DISENGAGED ON EACH ATTEMPT AS INTENDED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING AN ORIF-LEFT HIP FRACTURE SURGERY ON (B)(6) 2013, WHILE INSERTING THE HELICAL BLADE, THE SURGEON HAD ISSUES WITH THE BLADE GUIDE SLEEVE AND AIMING ARM. THE BLADE GUIDE OUTER SLEEVE WOULD NOT SLIDE OVER INNER SLEEVE. IN ADDITION, THE AIMING ARM BUTTON WOULD NOT WORK CORRECTLY. SURGEON REMOVED THE INSTRUMENTS AN EXPLANTED THE NAIL AND BLADE. ALL ITEMS WERE TESTED ON THE BACK TABLE WITH NO PROBLEM. SURGEON RE-IMPLANTED THE NAIL AND BLADE WITH NO ADDITIONAL ISSUES. DUE TO THIS EVENT AN ADDITIONAL 30 MINUTES WAS ADDED TO THE SURGERY TIME. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176238 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4764115

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention