BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L85 TAN

    MDR report key: 3141228 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-03026
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    January 31, 2011
    Report Date
    February 22, 2011
    Manufacturer
    SYNTHES (USA
    Product Code
    LXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL INFORMATION (B)(6). AFTER INSERTION OF THE BLADE INTO THE FEMORAL HEAD, THE DOCTOR LOCKED THE HELICAL PART OF THE BLADE WITH THE INSERTER DRIVER. THE SURGEON INSERTED THE BLADE FURTHER INTO THE FEMORAL HEAD. THE SURGEON RELEASED THE HELICAL PART OF THE BLADE BY THE INSERTER DRIVER. THE BLADE AND END PARTS DISASSEMBLED DURING THE OPERATION. THE DOCTOR SUSPECTS SOMETHING WAS WRONG WITH THE BLADE. ACCORDING TO EVALUATION FORM, PRODUCT WAS INVESTIGATED AND FOUND TO BE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. VISUAL INSPECTION OF THE PROXIMAL FEMORAL NAIL ANTIROTATION BLADE SHOWED THAT IT FELL APART BECAUSE THE LOCKING SCREW WAS TURNED OUT COMPLETELY. IT IS POSSIBLE THAT THE LOCKING SCREW WAS RELEASED TOO MUCH DURING THE PROCEDURE, RESULTING IN SEPARATING OF THE COMPLETE SYSTEM. ALL PARTS WERE CHECKED WITH THE PRINT SPECIFICATION AND NO DEVIATION COULD BE DETECTED. THE INVESTIGATION DETERMINED THIS COMPLAINT TO BE INVALID. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    AFTER INSERTION OF THE BLADE INTO THE FEMORAL HEAD, THE DOCTOR LOCKED THE HELICAL PART OF THE BLADE WITH THE INSERTER DRIVER. THE SURGEON INSERTED THE BLADE FURTHER INTO THE FEMORAL HEAD. THE SURGEON RELEASED THE HELICAL PART OF THE BLADE BY THE INSERTER DRIVER. THE BLADE AND END PARTS DISASSEMBLED DURING THE OPERATION. THE DOCTOR SUSPECTS SOMETHING WAS WRONG WITH THE BLADE.

    Description of Event or Problem · 1

    PROXIMAL FEMORAL NAIL ANTIROTATION BLADE DISASSEMBLED DURING OPERATION. THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244865 PFNA-II BLADE L85 TAN LXT SYNTHES (USA 2623420

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR