BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7946353

    MDR report key: 7946353 · Received October 9, 2018

    Report

    Report Number
    7946353
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 17, 2018
    Report Date
    September 26, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT INJURED HIS LEFT LEG WHILE INNER TUBING AND CRASHED INTO A DOCK, RESULTING IN AN OPEN TIB-FIB FRACTURE ON LEFT SIDE WITH A WOUND IN ANTEROLATERAL LEG OVER THE FRACTURE SITE. HE HAS DISPLACED THIRD METATARSAL SHAFT FRACTURE. DURING THE PLANNED PROCEDURE, THE SURGEON STARTED REAMING AND NOTED THE PATIENT HAD INCREDIBLY HARD BONE AND IT WAS HARD TO GET THE REAMER EVEN STARTED INTO THE PROXIMAL TIBIA. THE SURGEON WENT TO A SMALLER SIZE REAMER STARTING AT 6.5 AND THEN WORKING UP TO A 11 REAMER WITH A PLAN TO PLACE A 10 X 345 NAIL. ONCE THE SURGEON GOT THE REAMER TO THE FRACTURE SITE, A LOUD CRACK WAS APPRECIATED AND IT WAS OBVIOUS THAT THE REAMER HAD FRACTURED. THE SURGEON REMOVED THE PROXIMAL ASPECT OF THE REAMER AND THE GUIDE ROD. THE DISTAL ASPECT OF THE REAMER WAS STILL STUCK IN THE DISTAL ASPECT OF THE PROXIMAL FRAGMENT AND THERE WERE AT LEAST 100 SMALL FRAGMENTS OF REAMER WITHIN THE IM CANAL AND FRACTURE SITE. BECAUSE THERE IS NO WAY TO ACCESS THE REAMER HANDLE FROM THE PROXIMAL INCISION, THE SURGEON EXTENDED THE FRACTURE SITE INCISION AND USING THE END OF A SCREWDRIVER, DROVE IT UP THE PROXIMAL FRAGMENT, TAPPING THE REAMER BACK UP RETROGRADE TOWARDS THE KNEE. THE REAMER COULD BE ACCESSED THROUGH THE PROXIMAL INCISION ALTHOUGH IT WAS DIFFICULT TO PULL OUT. THE SURGEON SLOWLY PULLED IT OUT WITH A SMALL NEEDLE DRIVER. THEN THE SURGEON SPENT 30 MINUTES REMOVING AS MUCH OF THE SMALL FRAGMENTS OF REAMER THAT HE COULD BOTH AT THE FRACTURE SITE AND UNDERNEATH THE PROXIMAL INCISION. HE RE-PASSED A NEW GUIDEWIRE DOWN TO THE ANKLE AND REAMED UP TO 10 WITH GOING TO A SMALLER SIZE NEEDLE GIVEN THE PREVIOUS FRACTURE. A TIBIAL NAIL WAS ADVANCED PAST THE FRACTURE SITE WITH GOOD ALIGNMENT ON AP AND LATERAL VIEWS. THE SURGEON CONTINUED THE MEDIAL INCISION, INSERTING A 42 MM SCREW. WHEN THE PROCEDURE WAS COMPLETED, THE ENTIRE CONSTRUCT WAS VIEWED FLUOROSCOPICALLY AND LOOKED VERY ACCEPTABLE WITH SEVERAL SMALL FRAGMENTS STILL WITHIN THE IM CANAL OF THE TIBIA. PATIENT TOLERATED THE PROCEDURE WITHOUT FURTHER DIFFICULTIES AND LEFT SURGERY IN GOOD CONDITION. PATIENT WAS DISCHARGED TO HOME ON POST-OP DAY 3. THE BROKEN REAMER AND MULTIPLE FRAGMENTS WERE SAVED FOR FURTHER EXAMINATION.

    Patients

    Seq Age Sex Outcome Treatment
    0 11680 DA