BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 3760733 · Received April 21, 2014

    Report

    Report Number
    0008010177-2014-00099
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STRYKER LEIBINGER-FREIBURG
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE AFFECTED DEVICES WERE RETURNED IN GOOD LOOKING CONDITIONS. THE SURGEON REPORTED THAT THE PLATES EXCEEDED HIS EXPECTATIONS. THERE WAS A COLD WELDING WHICH IS SOMETHING IDENTIFIED AND DESCRIBED IN OUR LITERATURE (SEE EXTRACTION SET BROCHURE REF (B)(4)): "PLATES TO REMOVE ANY PLATE, FIRST EXTRACT ALL SCREWS BY USING THE APPROPRIATE SIZE SCREWDRIVER BITS. REMOVE THE PLATE BY USING A REGULAR FORCEPS. THE DEVELOPMENT OF LOCKING PLATE TECHNOLOGY HAS LEAD TO ¿COLD WELDING¿ OF SCREWS TO THE PLATES. IN THIS CASE, CUTTING TOOLS FOR METAL HAVE TO BE USED FOR THE REMOVAL OF THE SCREWS. IN ORDER TO PROTECT THE SOFT TISSUE FROM EXCESSIVE HEAT AND METAL DEBRIS ACCUMULATION, IRRIGATION AND SUCTION SHOULD BE USED IN COMBINATION WITH CUTTING TOOLS. WARNING: IF SCREWS ARE COLD WELDED TO THE PLATE, CARBIDE DRILLS MAY BE REQUIRED. THE EXTRACTION SET DOES NOT FEATURE CARBIDE DRILLS OR ANY OTHER INSTRUMENTS TO REMOVE COLD WELDED SCREWS." [ORIGINAL STATEMENT] THE DEVICES WERE REMOVED USING VARIAX SCREWDRIVERS. THOSE SCREWDRIVERS WERE NOT DESIGNED FOR THIS BRAND THEREFORE, THE HARDWARE REMOVAL WAS DIFFICULT BECAUSE OF COLD WELDING IN COMBINATION WITH WRONG INSTRUMENTATION USED. A FULL INVESTIGATION WILL BE PERFORMED ON THE 3 SCREWDRIVERS TO EXCLUDE ANY DESIGN/MANUFACTURING ISSUE, HOWEVER PLATES AND SCREWS ARE CONSIDERED AS CONCOMITANT IN THIS CASE AND CONTRIBUTED TO THE SUCCESS OF PATIENT'S HEALING.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A HARDWARE REMOVE ON A MALE PATIENT WHO HAD A LIS FRANC AND LAPIDUS CP IMPLANTED SEVERAL MONTHS PRIOR. WHEN I ARRIVED AT THE FACILITY, SURGEON HAD BEGUN THE CASE. HE IMMEDIATELY NOTIFIED ME THAT HE HAD BROKEN 4 SCREW DRIVER SHAFTS TRYING TO REMOVE THE IMPLANTED 2.5/3.5 SCREWS. ONLY 3 SHAFTS WERE COLLECTED AFTER THE CASE. THE MOST PROXIMAL LOCKING SCREW ALREADY HAD A BROKEN SHAFT LODGED IN THE SCREW HEAD DURING INSERTION, HE SAID HE WASN'T AWARE OF THAT AT THE TIME. AT THIS POINT, HE HAD ALSO TRIED ALL TORQUE HEAD SCREW DRIVER SHAFTS IN THE VARIAX PRODUCT LINE TO TRY AND REMOVE THE SCREWS THIS INCLUDED THE VARIAX FOOT, HAND, AND ANKLE. THE HOSPITAL ALSO PULLED ALL EXTRACTION SETS AND COMPETITIVE COMPANIES TORQUES HEADS TO TRY AND REMOVE THE SCREWS. HE WAS ABLE TO REMOVE SOME OF THE SCREWS IN BOTH PLATES. AS A LAST OPTION USED A BUR AND BURRED THE HEADS OF THE SCREWS AND USED AN OSTEOTOME TO LEVER THE PLATE UP FREEING THEM FROM THE SCREW. SOME OF THE SCREWS HE BACKED OUT OF THE BONE AND SOME HE USED A RONGUE TO GET OUT. FUSIONS WERE A SUCCESS 6-8 WEEKS AFTER INITIAL IMPLANTATION, SURGEON STATED THAT THE PLATES EXCEEDED HIS EXPECTATIONS. CASE ENDED IN A SUCCESS WITH ALL HARDWARE REMOVED.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A HARDWARE REMOVE ON A MALE PATIENT WHO HAD A LIS FRANC AND LAPIDUS CP IMPLANTED SEVERAL MONTHS PRIOR. WHEN I ARRIVED AT THE FACILITY SURGEON HAD BEGUN THE CASE. HE IMMEDIATELY NOTIFIED ME THAT HE HAD BROKEN 4 SCREW DRIVER SHAFTS TRYING TO REMOVE THE IMPLANTED 2.5/3.5 SCREWS. ONLY 3 SHAFTS WERE COLLECTED AFTER THE CASE. THE MOST PROXIMAL LOCKING SCREW ALREADY HAD A BROKEN SHAFT LODGED IN THE SCREW HEAD DURING INSERTION, HE SAID HE WASN'T AWARE OF THAT AT THE TIME. AT THIS POINT HE HAD ALSO TRIED ALL TORQUE HEAD SCREW DRIVER SHAFTS IN THE VARIAX PRODUCT LINE TO TRY AND REMOVE THE SCREWS THIS INCLUDED THE VARIAX FOOT, HAND, AND ANKLE. THE HOSPITAL ALSO PULLED ALL EXTRACTION SETS AND COMPETITIVE COMPANIES TORQUES HEADS TO TRY AND REMOVE THE SCREWS. HE WAS ABLE TO REMOVE SOME OF THE SCREWS IN BOTH PLATES. AS A LAST OPTION USED A BUR AND BURRED THE HEADS OF THE SCREWS AND USED AN OSTEOTOME TO LEVER THE PLATE UP FREEING THEM FROM THE SCREW. SOME OF THE SCREWS HE BACKED OUT OF THE BONE AND SOME HE USED A RONGUE TO GET OUT. FUSIONS WERE A SUCCESS 6-8 WEEKS AFTER INITIAL IMPLANTATION, SURGEON STATED THAT THE PLATES EXCEEDED HIS EXPECTATIONS. CASE ENDED IN A SUCCESS WITH ALL HARDWARE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239356 UNKNOWN_FRO_PRODUCT INSTRUMENT HXX STRYKER LEIBINGER-FREIBURG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other