BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3155010 · Received June 8, 2013

    Report

    Report Number
    3003787298-2013-00086
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE DHR WAS REVIEWED AND REWORK WAS FOUND ON P/N 357.372 LOT 6950240. THE REWORK REMOVED RESIDUE FROM THE INSIDE DIAMETER FOUND AT THE PASSIVATION OP.25. THE PARTS WERE INSPECTED AND ACCEPTED AFTER THE REWORK WAS PERFORMED. THIS REWORK IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS VISUAL ON THE INSIDE DIAMETER OF THE GUIDE SHAFT. REWORK WAS FOUND ON P/N 357.372.1 LOT 6872410. THE REWORK REMOVED RESIDUE FROM THE INSIDE DIAMETER FOUND AT THE PASSIVATION OP.32. THE PARTS WERE INSPECTED AND ACCEPTED AFTER THE REWORK WAS PERFORMED. THIS REWORK IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS VISUAL ON THE INSIDE DIAMETER OF THE GUIDE SHAFT. NO RELEVANT ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RETURNED AIMING ARM WAS MANUFACTURED IN APRIL 2011 AND IS OVER 2 YEARS OLD. THE RETURNED BLADE GUIDE SLEEVE WAS MANUFACTURED IN APRIL 2011 AND IS OVER 2 YEARS OLD. THE RETURNED HELICAL BLADE INSERTER WAS MANUFACTURED IN JUNE 2012 AND IS APPROXIMATELY 1 YEAR OLD. THE BUTTRESS COMPRESSION NUT LISTED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. BASED ON LOT NUMBER, IT IS KNOWN THAT IT'S DATE OF MANUFACTURE WAS MAY 15,2003 AND THEREFORE, IT IS OVER 10 YEARS OLD. COMPLAINT WAS RECEIVED STATING PARTS WERE DIFFICULT TO DISCONNECT FOR CLEANING AND STERILIZATION AND HAD TO BE FORCED APART. THE COMPLAINT CONDITION COULD BE REPLICATED WITH THE HELICAL BLADE INSERTER BUT NOT WITH THE OTHER PARTS. THIS COMPLAINT CONDITION IS CAUSED WHEN THE HAMMER MISSES THE HEAD OF THE COUPLING SCREW, THE EARS OF THE INDICATOR ARE ACCIDENTALLY HIT BY THE HAMMER. THIS MAY CAUSE THE PIN IN THE INDICATOR TO BE DAMAGED AND THEREFORE THE INDICATOR MAY SPIN FREELY OR IT MAY BECOME JAMMED. THIS IS DUE TO A KNOWN TECHNIQUE ISSUE RELATING TO THE USE OF THE HAMMER. THIS CAN BE CAUSED IF THE HAMMER MISSES THE HEAD OF THE HELICAL BLADE COUPLING SCREW AND INSTEAD HITS THE EARS OF THE INDICATOR. IT DOES NOT CAUSE A LOSS OF FUNCTION DURING THE CASE, AND IT DOES NOT POSE ANY SAFETY OR HEALTH CONCERNS. THE PURPOSE OF THE INDICATOR IS TO CAPTURE THE GOLD HANDLE ON THE INSERTER. IF THE TOP SPINS FREELY IT IS STILL HELD IN PLACE AND DOES NOT FALL OFF OF THE HELICAL BLADE INSERTER AND THEREFORE THE CASE CAN BE COMPLETED WITHOUT INCIDENT. IF THE INDICATOR BECOMES JAMMED IT STILL CAPTURES THE GOLD HANDLE AND THE CASE CAN BE EASILY COMPLETED. THE TROCHANTERIC FIXATION NAIL RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION AS LESS SEVERE. SPECIFICALLY, THE RISK ASSOCIATED WITH THE 12TH HAZARD LISTED UNDER INSTRUMENTATION ON ASSEMBLY INDICATOR TOP OF BLADE INSERTER EITHER BEING JAMMED OR FREELY SPINNING DUE TO SURGEON HAMMERING ON THE EARS OF THE INDICATOR INSTEAD OF THE COUPLING SCREW HEAD IS ASSESSED AS LESS SEVERE WITH A MARGINAL SEVERITY OF HARM 2 AND AN UNLIKELY PROBABILITY OF OCCURRENCE 2 WITH POSSIBLE HARMS LISTED AS INDICATOR FREELY SPINNING: DOES NOT INDICATE ORIENTATION OF BLADE, AND INDICATOR JAMMED: CANNOT DISASSEMBLE FOR CLEANING. THE COMPLAINT CONDITION OF STICKS/JAMS/STUCK IS CONFIRMED DURING THIS EVALUATION ONLY FOR THE HELICAL BLADE INSERTER. THE COMPLAINT CONDITION IS CAUSED BY INADVERTENT HAMMER BLOWS TO THE INDICATOR. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE THE AIMING ARM, BUTTRESS/COMPRESSION NUT, BLADE GUIDE SLEEVE AND HELICAL BLADE INSERTER COULD NOT BE DISASSEMBLED. THERE WAS NO PATIENT HARM AND NO ADDITIONAL TIME ADDED TO THE PROCEDURE. THE PARTS WERE FORCED APART FOR CLEANING AND STERILIZATION. THIS REPORT IS 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255638 HELICAL BLADE INSERTER LXH SYNTHES JENNERSVILLE 6950240

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR