BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TROCAR 210MM

    MDR report key: 4427339 · Received January 16, 2015

    Report

    Report Number
    3003875359-2015-10044
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 23, 2014
    Report Date
    December 23, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVIEWED THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE COMPLAINT CONDITION FOR THE 03.010.071 LOT NUMBER 8014250 5.0MM TROCAR, 210MM WAS LIKELY CAUSED BY MISUSE ON THE PART OF THE USER; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE 03.010.071 5.0MM TROCAR, 210MM IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL SYSTEM ((B)(4)).THE DEVICE WAS RETURNED AND REPORTED TO HAVE BECOME BENT WHEN ¿THE SURGEON GRABBED A TROCAR TO PUT THROUGH THE HANDLE INAPPROPRIATELY.¿ THIS CONDITION IS CONFIRMED; THE TROCAR SHOWS A VERY SIGNIFICANT BEND OF ROUGHLY FIFTEEN DEGREES FROM CENTER. IT IS LIKELY THAT THE DEVICE WAS MISUSED IN A WAY INCONSISTENT WITH THE TECHNIQUE GUIDE. THE DEVICE APPEARS TO HAVE BEEN EITHER JAMMED THROUGH THE PROTECTION SLEEVE, OR USED TO PRY OR LEVER SOMETHING. THE DEVICE WAS MANUFACTURED IN 9/2012 AND IS OVER TWO YEARS OLD. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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 DURING A DISTAL FEMUR FRACTURE SURGERY ON (B)(6) 2014, THAT THE INSERTION HANDLE FOR THE RETROGRADE NAIL (THE TOOTH) THAT CONNECTS TO THE NAIL SNAPPED OFF. THE SURGEON WAS UNABLE TO FIND THE FRAGMENT. IT WAS UNKNOWN IF THE FRAGMENT WAS RETAINED IN THE PATIENT OR NOT. THE DIRECTOR WILL ORDER X-RAYS TO CONFIRM. IT WAS ALSO REPORTED THAT THE SURGEON USED A TROCAR TO PUT THROUGH THE HANDLE INAPPROPRIATELY AND BENT THE TROCAR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL TIME DELAY AND/OR ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42362 5.0MM TROCAR 210MM GUIDE FZX SYNTHES HAGENDORF 8014250

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR