BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3® 8X35MM

    MDR report key: 6708276 · Received July 12, 2017

    Report

    Report Number
    0009610622-2017-00224
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    April 24, 2017
    Report Date
    September 1, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE NAIL HOLDING SCREW (NHS) TO BE THE PRIMARY PRODUCT; ALL OTHER PRODUCTS DID NOT CONTRIBUTE TO THE JAMMING AND WERE CLASSIFIED AS CONCOMITANT ITEMS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NHS RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR APPROX. 12 YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DIMENSIONAL, FUNCTIONAL OR MANUFACTURING RELATED ISSUES WERE FOUND. THE REPORTED EVENT WAS REPRODUCIBLE; THE NAIL STUCK ON THE TARGET DEVICE. AFTER DISASSEMBLING THE NAIL FROM THE TARGET DEVICE WITH TOOLS IT WAS FOUND THAT THE UPPER RIM OF THE NHS HEAD IS DEFORMED TWICE; FIRST, TWO DEEP DEFORMATIONS WERE VISIBLE, MOST LIKELY CAUSED BY THE THREAD OF A UNIVERSAL ROD, SECOND, THE WHOLE UPPER RIM OF THE NHS HEAD IS BULGED OUTWARDS, MOST LIKELY CAUSED BY AN INSERTED SCREWDRIVER STRIKE PLATE. DUE TO HAMMERING ON BOTH INSTRUMENTS THE NHS HEAD GOT DEFORMED SO THAT THE NHS GOT JAMMED WITHIN THE TARGET DEVICE. THE OPERATIVE TECHNIQUE INCLUDES THAT HAMMERING DIRECTLY ON THE NHS OR TARGET DEVICE IS NOT ALLOWED. A NEW TARGET DEVICE WAS DESIGNED (CAT# 13200111), INCLUDING A SLOT FOR THE STRIKE PLATE (CAT# 18060150) TO MAKE NAIL INSERTIONS BY HAMMERING POSSIBLE. THE SCREWDRIVER STRIKE PLATE IS DESIGNED TO SCREW OUT THE NHS OR TO INSERT/EXTRACT END CAPS; THE UNIVERSAL ROD IS DESIGNED FOR NAIL REMOVAL ACCORDING TO THE OPERATIVE TECHNIQUE. BASED ON THE INVESTIGATION RESULTS THE CASE IS ATTRIBUTED TO A MISUSE BY THE USER. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES, RISK ANALYSIS AND LABELLING DID NOT IDENTIFY ANY DISCREPANCIES. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT(S). NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHARMACIST AT THE HOSPITAL THAT DURING A PROCEDURE, THE NAIL REMAINED BLOCKED IN THE NAIL HOLDER AND IT WAS IMPOSSIBLE TO RETRIEVE IT. SO THE MEDICAL STAFF HAD TO REMOVE THE NAIL BY FORCE ( SIGNIFICANT DIFFICULTY ) THE SURGERY WAS DELAYED. THE PROCEDURE COMPLETED WELL BY USING ANOTHER NAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHARMACIST AT THE HOSPITAL THAT DURING A PROCEDURE, THE NAIL REMAINED BLOCKED IN THE NAIL HOLDER AND IT WAS IMPOSSIBLE TO RETRIEVE IT. SO THE MEDICAL STAFF HAD TO REMOVE THE NAIL BY FORCE ( SIGNIFICANT DIFFICULTY ) THE SURGERY WAS DELAYED. THE PROCEDURE COMPLETED WELL BY USING ANOTHER NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489865 NAIL HOLDING SCREW GAMMA3® 8X35MM INSTRUMENT LXH STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other