BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3013512 · Received March 20, 2013

    Report

    Report Number
    1719045-2013-10378
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORD REVEALED THAT THE LOCKING HOLDING SLEEVE - STANDARD FOR MATRIX WAS MANUFACTURED BY RMS COMPANY. RMS COMPANY'S CERTIFICATE OF COMPLIANCE INDICATED THE PARTS WERE MANUFACTURED TO THE CORRECT MATERIAL REQUIREMENTS AND MET THE REQUIRED SPECIFICATIONS. BOTH LOCKING HOLDING SLEEVES WERE RETURNED WITH MINOR SCRATCHES AND VISIBLE SIGNS OF WEAR. MANUFACTURING EVALUATION REVEALED COSMETIC NON-CONFORMANCES AT THE TIPS AND HEAVY BURRS, NICKS AND DINGS ON THE THREADS, INDICATIVE OF USE. ON ONE PART COULD BE NOTICED TWO AREAS WHERE ANODIZE WAS WORN AWAY ON THE SIDES. BOTH INSTRUMENTS FUNCTIONED PROPERLY AND THE LOCKING RINGS COULD BE PULLED UP WITH SOME RESISTANCE. RMS COMPANY ALSO EVALUATED THE RETURNED PRODUCT. QUALITY ENGINEERING VISUALIZED THE THREADED AREA UNDER THE MICROSCOPE AT 10X MAGNIFICATION AND FOUND ABNORMALITIES PRESENT ON THE LEAD THREAD, INSIDE CANNULATION AND GENERAL THREADED AREA. IT APPEARED THAT FORCE WAS USED DURING THE THREADING IMPLANT ONTO THE INSTRUMENT, DAMAGING THE LEAD THREAD. THIS CONDITION IS POSSIBLE IF THE IMPLANT COMPONENT WAS NOT SEATING IN A PERPENDICULAR POSITION TO THE INSTRUMENT AT THE TIME OF ENGAGING THE FIRST THREAD, THEN FORCE USED TO GET THE IMPLANT ONTO THE INSTRUMENT. A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED. ON THE DEVICE LABELED 1-1, THE DISTAL TIP APPEARED TO BE DEFORMED OUT OF ROUND WHEN VIEWED DOWN THE AXIS OF THE INSTRUMENT. THIS IS INDICATIVE OF THE INSTRUMENT BEING DROPPED OR OTHERWISE MISHANDLED. ON THE DEVICE LABELED 2-1, THE VERY TIP OF THE THREADS AT THE DISTAL END WERE SLIGHTLY DEFORMED. THIS COULD HAVE BEEN CAUSED BY CROSS THREADING THE INSTRUMENT ONTO THE SCREW OR BY MISHANDLING THE INSTRUMENT. THE INSTRUMENT STILL FUNCTIONED PROPERLY AND COULD BE LOADED ONTO A SCREW WITHOUT ISSUE. THE DESIGN EVALUATION SHOWED THAT THE TECHNIQUE GUIDE DESCRIBES THE PROPER USE OF THE INSTRUMENT. DEVICE 1-1 APPEARS TO HAVE BEEN MISHANDLED. THE CAUSE OF THE DAMAGE TO DEVICE 2-1 COULD NOT BE DETERMINED. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING AND THE EVALUATION PERFORMED BY SYNTHES AND RMS COMPANY, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. PLACEHOLDER.

    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.THIS IS REPORT 1 OF 1 FOR COMPLAINT 5250 AND IS FOR TWO LOCKING HOLDING SLEEVES STANDARD FOR MATRIX.(B)(4)

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR FUSION PROCEDURE AT L4-S1, THE SURGEON NOTED THE TIP OF THE SCREWDRIVER FRAYED AFTER PLACING A SCREW. THE TIP APPEARED TO HAVE A THIN WIRY METAL SHARD STICKING OUT OF THE THREADS. THE SAME THING HAPPENED TO THE SECOND SCREWDRIVER HE USED. A THIRD SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT 5250 AND IS FOR TWO LOCKING HOLDING SLEEVES STANDARD FOR MATRIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116565 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6738069

    Patients

    Seq Age Sex Outcome Treatment
    1