BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH

    MDR report key: 3010236 · Received March 19, 2013

    Report

    Report Number
    2530088-2013-10257
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. AFTER REVIEWING THE DHR FOR ALL MATERIAL, COMPONENTS AND ASSEMBLIES, NO DISCREPANCIES WERE FOUND THAT COULD BE RELATED TO THE COMPLAINT CONDITION. THE PART WAS RECEIVED WITH THE POLYAXIAL HEAD SEPARATED FROM THE SCREW AS NOTED IN THE COMPLAINT. THE POLYAXIAL HEAD HAD LARGE SCRAPES ON BOTH SIDES AND ON ONE END AROUND THE GROOVE FOR THE ROD. THE DESIGN IS ACCEPTABLE AND THE COMPLAINT IS INVALID FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE SCREW HAD LARGE GOUGES IN THE 4TH AND 5TH THREADS FROM THE HEAD BUT WAS OTHERWISE UNDAMAGED. THE HEAD WAS REASSEMBLED TO THE SCREW EASILY AND HELD SECURELY AND COULD ONLY BE REMOVED WITH THE APPROPRIATE TOOL. THE LOCKING CAP WAS INSERTED INTO THE TOP OF THE HEAD WITHOUT DIFFICULTY. MATRIX IS A MODULAR DESIGN AND THE HEAD IS DESIGNED TO BE CAPABLE OF BEING REMOVED FROM THE BONE SCREW IN CASE OF DAMAGE OR CHANGE IN SURGICAL PREFERENCE. IF THE HEAD IS REMOVED DURING SURGERY A NEW HEAD OR DIFFERENT STYLE HEAD CAN BE REPLACED WITHOUT THE NEED TO REPLACE THE BONE SCREW. A TOOL IS PROVIDED IN THE SET TO REMOVE HEADS FROM BONE SCREWS WITHOUT DAMAGING THE BONE SCREW. THE ROCKING MOTION DESCRIBED IN THE COMPLAINT IS CONSISTENT WITH THE MOTION REQUIRED TO REMOVE THE HEAD AND IS MOST LIKELY THE CAUSE OF THE SEPARATION. THE HEAD WAS REASSEMBLED WITHOUT DIFFICULTY TO THE SCREW AND THE POLYAXIAL HEAD RETAINED SECURELY ON THE SCREWS AS DESIGNED AND COULD ONLY BE REMOVED WITH THE PROPER TOOL. THE LOCKING CAP WAS ASSEMBLED WITHOUT ISSUE AS WELL AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE POLYAXIAL HEAD IS REMOVABLE AND THE USE OF THE ROCKER FORK AND PERSUADER AND THE SURGICAL TECHNIQUE BEING USED MOST LIKELY CAUSED THE HEAD TO SEPARATE PRIOR TO INSTALLATION OF THE LOCKING CAP. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR T10 TO ILLIUM PROCEDURE, THE SURGEON WAS INSTALLING THE LEFT SIDE LOCKING CAPS WHEN THE HEAD OF ONE OF THE SCREWS POPPED OFF. THE SURGEON WAS REDUCING THE SCREW USING A ROCKER FORK AND SIMPLE PERSUADER WHEN IT OCCURED. THE SURGEON REMOVED THE SCREW AND USED ANOTHER IN ITS PLACE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EFFECT ON PATIENT. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113323 7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6681026

    Patients

    Seq Age Sex Outcome Treatment
    1