BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL NAIL T2 HUMERUS Ø8X230 MM

    MDR report key: 3852601 · Received June 6, 2014

    Report

    Report Number
    0009610622-2014-00267
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT INQUIRY STATES THE HUMERAL NAIL T2 TO BE THE SUBJECT PRODUCT. THE REPORTED TARGET DEVICE AND NAIL HOLDING SCREW, WHICH WERE NOT RETURNED, ARE CONSIDERED CONCOMITANT PRODUCTS. TECHNICAL ASPECTS: REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DIMENSIONAL INSPECTION OF THE NAIL IN THE NON-DAMAGED AREAS REVEALED NO DEVIATION. WITH RESPECT TO THE APPEARANCE OF DAMAGE FOUND AND ACCORDING TO THE REPRODUCTION OF THE SCENARIO WITH SAMPLE DEVICES IT APPEARS BEING UTMOST LIKELY THAT THE NAIL HOLDING SCREW HAD NOT BEEN INSERTED TO THE SUFFICIENT LENGTH AND THAT THE NAIL WAS DAMAGED WHILST IT WAS FIXED ON THE TARGET DEVICE IN A WRONG POSITION - 180° TURNED (CONTRARY) TO THE INTENDED POSITION. IF THE NAIL IS ATTACHED IN THIS (WRONG) POSITION IT IS NOT POSSIBLE TO INSERT THE NAIL HOLDING SCREW TO THE FULL LENGTH OF THE THREAD AS THE PEGS OF THE TARGET DEVICE DON¿T FIT INTO THE SEATING SLOTS OF THE NAIL. THIS IS CAUSED BY AN INTENDED FEATURE AT THE NAIL RECEPTION OF THE TARGET DEVICE: THE PEGS ARE NOT CENTRICALLY / SYMMETRICALLY ARRANGED WHICH ONLY ALLOWS ADAPTING THE NAIL IN ONE DIRECTION; OTHERWISE THE RECEPTION OF THE NAIL WOULD BE SIGNIFICANTLY DAMAGED. APPEARANCE OF DAMAGE FOUND INDICATES THAT THE NAIL HOLDING SCREW HAD BEEN TIGHTENED BY FORCE WHILST THE NAIL WAS FIXED IN A WRONG POSITION (180° TURNED (CONTRARY) TO THE INTENDED POSITION) ON THE TARGET DEVICE. THIS HAD CAUSED THE BREAKAGE OF THE NAIL RECEPTION. ROTATING THE TARGET DEVICE (AND THE WRONGLY ADAPTED AND PRE-DAMAGED NAIL) MANUALLY UNDER HIGH FORCE MOST LIKELY HAD COMPLETED THE SHEARING OF THE NAIL RECEPTION. SIMILAR DAMAGE WAS FOUND AT NAILS OF PREVIOUS CASES WHERE THE NAILS HAD BEEN ATTACHED IN A WRONG POSITION. SUCH KIND OF SHEARING OFF IS ONLY POSSIBLE UNDER CONSIDERABLE FORCE APPLICATION. MEDICAL ASPECTS:THE INFORMATION AVAILABLE WAS FORWARDED TO A HCP FOR REVIEW. HIS COMMENTS: ¿CONCERNING THE REMAINING NAIL FRAGMENTS/DEBRIS NO HARM HAS TO BE EXPECTED BECAUSE THEY ARE PROBABLY LOCATED INSIDE THE BONE WITHOUT TENDENCY OF MIGRATION. EXCELLENT BIOCOMPATIBILITY OF THE FRAGMENTS/DEBRIS IS PROVEN. FROM A CLINICAL POINT OF VIEW NO ADDITIONAL MEASURES ARE REQUIRED.¿ BASED ON THE ABOVE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER USER RELATED TO NON-INTENDED USE (DEVIATION FROM SURGICAL TECHNIQUE). NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WE PROPERLY ATTACHED A STANDARD HUMERAL NAIL TO THE NAIL TARGET DEVICE WITH THE NAIL HOLDING SCREW. THE DOCTOR INSERTED THE NAIL MANUALLY ABOUT HALF WAY DOWN THE PATIENTS' HUMERUS. THE SURGEON THEN USED LIGHT IMPACTION WITH THE MALLET TO FULLY INSERT THE NAIL. ONCE THE NAIL WAS DOWN TO THE DESIRED DEPTH THE SURGEON TRIED TO CHANGE THE VERSION OF THE NAIL BY GRABBING THE TARGETING DEVICE WITH IS HANDS AND ROTATING IT INSIDE THE PATIENTS' CANAL. WHILE DOING THIS, THE MOST PROXIMAL MILLIMETER OR SO OF THE NAIL ALONG WITH THE TABS STRIPPED OFF. WE USED A 1 MM LARGER DIAMETER NAIL OF THE SAME LENGTH TO FINISH THE OPERATION.

    Description of Event or Problem · 1

    WE PROPERLY ATTACHED A STANDARD HUMERAL NAIL TO THE NAIL TARGET DEVICE WITH THE NAIL HOLDING SCREW. THE DOCTOR INSERTED THE NAIL MANUALLY ABOUT HALF WAY DOWN THE PATIENTS' HUMERUS. THE SURGEON THEN USED LIGHT IMPACTION WITH THE MALLET TO FULLY INSERT THE NAIL. ONCE THE NAIL WAS DOWN TO THE DESIRED DEPTH THE SURGEON TRIED TO CHANGE THE VERSION OF THE NAIL BY GRABBING THE TARGETING DEVICE WITH IS HANDS AND ROTATING IT INSIDE THE PATIENTS' CANAL. WHILE DOING THIS, THE MOST PROXIMAL MILLIMETER OR SO OF THE NAIL ALONG WITH THE TABS STRIPPED OFF. WE USED A 1 MM LARGER DIAMETER NAIL OF THE SAME LENGTH TO FINISH THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332041 HUMERAL NAIL T2 HUMERUS Ø8X230 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K932446

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other