BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3880006 · Received June 18, 2014

    Report

    Report Number
    2530088-2014-10163
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE RELEVANT DRAWING WAS REVIEWED AND IS DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY. THE HELICAL BLADE INSERTER SHOWS EXTENSIVE USE DURING ITS NINE YEAR LIFESPAN. THE GOLD HANDLE HAS NUMEROUS GOUGES, SCRATCHES, AND DENTS FROM REPEATED HAMMER BLOWS AND PLIERS. THE T-HANDLE FREELY SPINS AND THE RETAINING SCREW IS BROKEN OFF. THE DISTAL TIP IS DENTED AND DEFORMED. THE RETURNED INSTRUMENT ARE PART OF THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN); AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN TECHNIQUE GUIDE. THE INSERTER IS USED TO ORIENT AND INSERT HELICAL BLADES TO PROXIMALLY LOCK TROCHANTERIC FIXATION NAILS. THE INTERNAL PIN THAT PREVENTS ROTATION OF THE T-HANDLE IS DEFORMED AND WORN TO THE POINT THAT IT IS INEFFECTIVE IN PREVENTING ROTATION. ADDITIONALLY, THE RETAINING SCREW THAT KEEPS THE T-HANDLE ATTACHED HAS BEEN BROKEN OFF AND IS MISSING. THIS DAMAGE AND COMPLAINT CONDITION IS DUE TO INADVERTENT HAMMER BLOWS TO THE HANDLE, RATHER THAN HAMMERING ON THE COUPLING SCREW. THIS COMPLAINT CONDITION IS A RESULT OF EXTENSIVE, INADVERTENT HAMMER BLOWS, NOT THE DEVICE'S DESIGN. BECAUSE OF THIS, THE COMPLAINT IS DETERMINED NOT TO BE A DESIGN DEFICIENCY. THE RETURNED PART ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HELICAL BLADE INSERTER FROM A TROCHANTERIC NAIL LOCKING SET WAS DISCOVERED TO BE BROKEN. THE SET WAS RECEIVED IN THE OPERATING ROOM WITH THE INSERTER MISSING. IT WAS FOUND IN STERILE PROCESSING UNSTERILIZED BECAUSE THE SET SCREW WAS BROKEN. THE EVENT IS NOT RELATED TO ANY SPECIFIC PATIENT OR CASE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357649 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5120691

    Patients

    Seq Age Sex Outcome Treatment
    1