BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3072444 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-11070
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE ROD INTRODUCTION PLIERS BROKE WHILE ATTEMPTING TO IMPACT THE COLLAR DOWN. BOTH DEVICES BROKE AT THE INTERFACE BETWEEN THE COLLET BODY (388.509.6) AND COLLET HANDLE (388.509.7). (B)(4). THE NUT (388.509.2) THAT SECURES THE PERSUADER TUBE TO THE HANDLE HAS SIGNIFICANT DENTS AND GOUGES ON THE TOP SURFACE ON BOTH DEVICES AND HAS BROKEN OFF ON ONE. THE TIPS OF THE COLLET HANDLE SET SCREWS (388.50.5) HAVE NUMEROUS DENTS AND GOUGES ON THE TIP AND ALONG THE SIDES. THIS SCREW MAINTAINS ALIGNMENT OF THE COLLET WITH THE PERSUADER TUBE AS IT SLIDES ALONG THE PART AND THE DENTS AND GOUGES ARE INDICATIVE OF HEAVY USE AND FORCE. ON THE DEVICE WITH THE BROKEN NUT, THE RATCHET MECHANISM HAS BECOME SEPARATED FROM THE HANDLE ASSEMBLY. THE TOP SURFACE HAS EVIDENCE OF MALLET BLOWS AND THE SPRING THAT HOLDS THE END INTO THE GROOVES ON THE HANDLE IS BENT BACK AND TO ONE SIDE SO THAT IT EXERTS MINIMAL PRESSURE ON THE RATCHET WHEN REASSEMBLED. IT IS LIKELY THAT THE BROKEN COMPONENT WAS THE RESULT OF IMPACTION FORCES APPLIED TO THE SUBCOMPONENT DURING AN ATTEMPT TO SEAT THE COLLAR. SEVERE PATIENT ANATOMY COULD CONTRIBUTE HIGH IN-SITU FORCES MAKING ROD REDUCTION, SEATING OF THE COLLAR/NUT DIFFICULT AND COULD PLACE HIGH LOADS ON THE HOOK/SCREW HOLDER. IT IS UNCLEAR WHAT TYPES OF CONSTRUCT, OR FORCES WERE PRESENT DURING SURGERY. REVISION A OF THE RISK ANALYSIS, LINE 20, APPLIES TO THIS COMPLAINT AS IT REFERS TO A BROKEN PERSUADER AND IT IS MAINTAINED IN THE PAPER-BASED DHF IN THE VEPTR PROJECT CABINET. THE RISK ANALYSIS IS ON (B)(4) (DESIGN AND CLINICAL RISK MANAGEMENT) AND WAS SIGNED INTO EFFECT IN (B)(4) 2010. THESE DEVICES WERE MANUFACTURED IN FEBRUARY 2003 AND FEBRUARY 2007 AND ARE ALMOST 10 AND 6 YEARS OLD RESPECTIVELY AND THE DAMAGE ON THE COMPONENTS INDICATES THAT THEY WERE STRUCK WITH FORCE REPEATEDLY OVER THAT TIME. A REVIEW OF THE SYSTEM INDICATES THE SYSTEM DESIGN IS APPROPRIATE FOR ITS INTENDED USE, AND THE COMPLAINT CONDITION WAS CAUSED BY STRIKING THE COMPONENTS TO IMPACT THE COLLARS INTO POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T12-ILIUM POSTERIOR FUSION, THE SURGEON BROKE TWO ROD REDUCTION PERSUADERS WHILE ATTEMPTING TO IMPACT THE COLLAR DOWN. BOTH PERSUADERS BROKE OFF IN THE SAME LOCATION. SURGEON HAD ADDITIONAL PERSUADERS AVAILABLE AND USED THEM TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, AND NO HARM TO PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173807 ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS HTC SYNTHES GMBH A7MA06

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR