BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS

    MDR report key: 3103147 · Received May 9, 2013

    Report

    Report Number
    1719045-2013-01427
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DHR : A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT NUMBER 6236691 REVEALED THE ROD INTRODUCTION PLIERS WERE MANUFACTURED BY (B)(4). (B)(4) DATED 9/30/09, FOR (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 9/30/09. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PLIERS ARE FROM LOT # A7SA39 WHICH WAS RECEIVED ON 9/30/09. THE COLLET ASSEMBLY IS MISSING AND WAS NOT RETURNED. THE SET SCREW IS MEANT TO KEEP THIS COLLET ASSEMBLY FROM DISASSEMBLING AND REMAIN WITHIN THE GROOVE OF THE COLLAR INSERTION SHAFT. THE CHU ENGINEER REVIEWED THE RELEVANT ENGINEERING DRAWING 388_509 REV E. THE SET SCREW IS NOT SECURED INTO THE ASSEMBLY USING ADHESIVE PER THE ENGINEERING DRAWING NOR IS THE DEPTH THAT THE SET SCREW IS PLACED SPECIFIED. THE ASSEMBLY CAN SLIP OFF COMPLETELY DURING USE IN THIS CONDITION. AS VISUAL INSPECTION REVEALED THERE ARE NO SCRATCHES ON THE SHAFT, IT LOOKS AS IF THE SET SCREW WAS MISSING OR BACKED OUT TOO FAR FOR THE COLLET ASSEMBLY TO REMAIN ASSEMBLED TO THE UPPER LEVEL ASSEMBLY. AS THE SURGEON IMPACTED THE COLLET ASSEMBLY FELL OFF THE REMAINDER OF THE INSTRUMENT. THE DESIGN OF THE ASSEMBLY DOES NOT INCLUDED ADEQUATE MEANS TO HOLD THE COLLET VIA SET SCREW TO THE UPPER LEVEL ASSEMBLY. THIS CAN LEAD TO THE SUB-ASSEMBLY FALLING OFF, JAMMING, OR INCORRECT ORIENTATION TO OCCUR. THIS COMPLAINT IS VALID FROM A DESIGN PERSPECTIVE. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Additional Manufacturer Narrative · 1

    DEVICE IS FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: (B)(6). PRODUCT DEVELOPMENT EVALUATION-THE DUAL-OPENING USS SYSTEM INCLUDES A ROD INTRODUCTION PLIERS TO INTRODUCE THE ROD INTO THE SIDE OPENING SCREW. THE USER LOADS ONE OF THE FOUR COLLARS (299.292, 299.293, 499.292, AND 499.293). THE SURGEON THEN POSITIONS THE INSTRUMENT OVER THE HOOK/SCREW HOLDER (388.612) THRU THE PERSUADER TUBE COMPONENT. NEXT THE USER ENGAGES THE ROD WITH THE JAWS AND SQUEEZES AND ROCKS THE HANDLE TO ALIGN THE SCREW AND ROD. THE COLLET IS DESIGNED TO PUSH THE COLLAR ONTO THE THE SCREW/ROD CONSTRUCT. THE PLIERS ARE FROM LOT # A7SA39 WHICH WAS RECEIVED ON 9/30/09. THE COLLET ASSEMBLY IS MISSING AND WAS NOT RETURNED. THE SET SCREW IS MEANT TO KEEP THIS COLLET ASSEMBLY FROM DISASSEMBLING AND REMAIN WITHIN THE GROOVE OF THE COLLAR INSERTION SHAFT. THE CHU ENGINEER REVIEWED THE RELEVANT ENGINEERING DRAWING 388_509 REV E. THE SET SCREW IS NOT SECURED INTO THE ASSEMBLY USING ADHESIVE PER THE ENGINEERING DRAWING NOR IS THE DEPTH THAT THE SET SCREW IS PLACED SPECIFIED. THE ASSEMBLY CAN SLIP OFF COMPLETELY DURING USE IN THIS CONDITION. AS THERE ARE NO SCRATCHES ON THE SHAFT, IT LOOKS AS IF THE SET SCREW WAS MISSING OR BACKED OUT TOO FAR FOR THE COLLET ASSEMBLY TO REMAIN ASSEMBLED TO THE UPPER LEVEL ASSEMBLY. AS THE SURGEON IMPACTED THE COLLET ASSEMBLY WHICH FELL OFF THE REMAINDER OF THE INSTRUMENT. THIS INSTRUMENT IS CURRENTLY MANUFACTURED IN (B)(4). MANUFACTURING HAS AGREED THAT THIS NEEDS TO BE ADDRESSED. THE CHU ENGINEER REVIEWED HAZARD ANALYSIS FOR USS-II, S00-004. THIS DOCUMENT DOES NOT ADEQUATELY ADDRESS THE HAZARD OF THIS COMPLAINT. THE DESIGN OF THE ASSEMBLY DOES NOT INCLUDED ADEQUATE MEANS TO HOLD THE COLLET VIA SET SCREW TO THE UPPER LEVEL ASSEMBLY. THIS CAN LEAD TO THE SUB-ASSEMBLY FALLING OFF, JAMMING, OR INCORRECT ORIENTATION TO OCCUR. THIS COMPLAINT IS VALID FROM A DESIGN PERSPECTIVE. PRODUCT DEVELOPMENT EVENT EVAL-THE 388.612 IS A SCREW/HOOK HOLDER FOUND IN THE DUAL OPENING USS SPINAL SYSTEM. THE HOOK/SCREW HOLDER IS USED IN COMBINATION WITH THE HANDLE (388.622) TO RETAIN AND INSERT THE DUAL OPENING SCREWS AND HOOKS INTO THE PEDICLES. THE LOT # 4528222 WAS RECEIVED ON 5/28/2003. THIS LOT WAS MANUFACTURED TO REV D OF DRAWING 388_612_1. HOWEVER, THERE ARE NO CHANGES TO MATERIAL OR DIMENSIONS OF THE RELEVANT THREAD DESIGN IN THE LATEST REV E THAT CHANGE THE STRENGTH OF THE THREADED TIP. THE MATERIAL (17-4 PH HEAT TREADED SS) IS ADEQUATE FOR THE DEVICES INTENDED USE. SINCE TORQUE IS ONLY APPLIED THROUGH THE HEX FEATURE WHEN FULLY ENGAGED IN THE SCREW, THE SURGEON MAY HAVE APPLIED A BENDING LOAD WHICH EXCEEDED THE TENSILE STRENGTH OF THE MATERIAL CAUSING THE FRACTURE. (B)(4) ENGINEER REVIEWED RISK ANALYSIS IN AGILE (B)(4). THE RISK OF SLIGHT ELONGATION OF TIME (IMPLANT RETRIEVAL AND REPLACEMENT) DUE TO EXCESSIVE TORQUE IS NOT DOCUMENTED IN THE RISK ANALYSIS. CAPA INITIATED. EXPLANT REPORTED IN ERROR; THIS IS AN INSTRUMENT NOT IMPLANTED.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE COMPLAINT ISSUE IS DUE TO AN UNKNOWN CAUSE. THE INSTRUMENT CONFORMED TO SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED SYNTHES INCOMING INSPECTION. THE MATERIAL AND HARDNESS REQUIREMENTS ON THE RETURNED DEVICE MET SPECIFICATIONS. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. DHR TO BE LAUNCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A L5 S1 FUSION SURGERY ON (B)(6) 2013, WHILE THE SURGEON WAS IMPLANTING A SCREW IN PEDICLE IN PATIENTS LUMBAR SPINE (UNKNOWN PEDICLE LOCATION), THE THREADS OF SCREW HOLDER BROKE IN THE HEAD OF THE SCREW. THE SURGEON WAS ABLE TO TAKE OUT AND REPLACE IT WITH A NEW ONE. THE SURGEON THEN ATTEMPTED TO PERSUADE THE ROD TO THE HEAD OF A SCREW DURING THE SAME PROCEDURE, USING A MALLET HOOK POSITIONER TO SEAT THE COLLAR ONTO THE ROD AND THE SCREW, WHEN THE PERSUADER BROKE. THE SURGEON THEN USED A NEW PERSUADER AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EVENT TO PATIENT. THIS REPORT IS FOR A ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS. THIS IS 2 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204134 ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS HTC SYNTHES MONUMENT A7SA39

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR