BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX 8 DRIVE SHAFT

    MDR report key: 3832334 · Received February 10, 2014

    Report

    Report Number
    1651501-2014-00005
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Report Date
    January 29, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF THREE CONCERNING THE SAME PATIENT. THIS REPORT CONCERNS PRODUCT ID 5010010 (TORX 8 DRIVE SHAFT) THAT BROKE OFF IN THE HEAD OF A SCREW DURING SURGERY. IT WAS REPORTED (ON AN UNKNOWN DATE) FOLLOWING A PROXIMAL HUMERAL FRACTURE SURGERY, THE PLATE PULLED OUT AND A SCREW BACKED OUT OF THE BONE. THE SURGEON SAID, SHE FELT THAT THE PLATE PULLED OUT OF THE BONE DUE TO BAD BONE QUALITY, INADEQUATE FRACTURE REDUCTION AND NONCOMPLIANT ACTIVITY BY THE PATIENT. THE SURGEON SAID, THE FRACTURE WAS REDUCED WHEN IT WAS CHECKED WITH THE C-ARM INTRA-OPERATIVELY, BUT SOON AFTER THE CASE WAS FINISHED (TIME UNSPECIFIED, THE (HUMERAL) HEAD HAD COLLAPSED. THE HEAD HAD A FRACTURE THAT SPLIT IT DOWN THE MIDDLE. ALTHOUGH, THE SURGEON FELT IT WAS FAIRLY WELL FIXED ANTERIORLY AND POSTERIORLY SHE SENT THE X-RAYS TO A DIFFERENT SURGEON WHO SAID THE PLATE COULD HAVE BEEN PLACED A LITTLE HIGHER (MORE PROXIMATELY) FOR MORE SCREWS TO GO IN THE SUPERIOR PORTION OF THE HEAD. TWO DAYS POSTOPERATIVELY, THE PATIENT TOOK THE SPLINT OFF AND DID YARD WORK. THE PATIENT REPORTEDLY DID NOT FOLLOW THE SURGEON'S INSTRUCTIONS TO REMAIN IMMOBILE. ON AN UNKNOWN DATE, THE SURGEON REMOVED THE PLATE AND SCREWS AND IMPLANTED A HEMI ARTHROPLASTY. SHE SAW THE PATIENT AT SIX WEEKS POST OPERATIVELY AND THE PATIENT WAS REPORTED AS 'DOING GREAT.' DURING THE REMOVAL SURGERY, THE TORX 8 DRIVE SHAFT TIP BROKE OFF IN THE HEAD OF A SCREW WHEN THE SURGEON INSERTED ONE OF THE SCREWS IN THE HEAD PORTION OF THE HUMERUS. A BACKUP DRIVER WAS UTILIZED AND THE SURGERY WAS COMPLETED. THE SURGEON SAID, SHE COULD NOT ATTRIBUTE THE INCIDENTS TO THE PLATE (OR SYSTEM) PERFORMANCE. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE REPORTER INDICATED THE SURGEON DID NOT WANT TO BE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87593 TORX 8 DRIVE SHAFT HUMERAL PLATING SYSTEM HRS ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1