BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3040405 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-00430
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    SYNTHES MONUMENT
    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

    THERE WERE TWO LOT NUMBERS WITH THIS DEVICE HISTORY RECORD REVIEW FOR THE ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL FOR 6.0 MM RODS. BOTH LOTS WERE MANUFACTURED BY (B)(4) AND INSPECTED, CONFORMED TO THE SYNTHES INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THESE LOTS. A MANUFACTURING EVALUATION WAS CONDUCTED. THE PLIERS EXHIBITED MINOR SCUFFMARKS. DUE TO AN UNKNOWN CAUSE, THE COLLET BODY AND THE COLLET HANDLE WERE DETACHED. THE COLLET SUB-ASSEMBLY WHICH INCLUDES THE COMPONENT PARTS, COLLET BODY, 388.509.6, AND COLLET HANDLE, 388.509.7 CONTAINS CONTAMINATION ON BOTH ITEMS WHERE THE SEPARATION OCCURRED. BASED ON THE EVALUATION AND THE UNKNOWN ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE PLIERS WERE RECEIVED WITH SOME MINOR SCRATCHES. THE COLLAR PUSHER ASSEMBLY IS FRACTURED. THE PLIERS FAILED AT THE SILVER BRAZING INTERFACE. THE SET SCREW IS ALSO ABLE TO FREELY ADVANCE OR BACK OUT. THE DESIGN HAS ADEQUATE CLEARANCE BETWEEN THE COLLAR PUSHER AND THE TUBE OF THE PLIERS WHICH WOULD NOT REQUIRE SUCH EXCESSIVE FORCE TO ADVANCE THE COLLAR ONTO THE CONSTRUCT. THE TECHNIQUE GUIDE STATES TO TAP THE COLLAR, BUT DOES NOT SPECIFY ANY HARD IMPACTION TO BE PERFORMED. THE COLLAR PUSHER MAY HAVE BEEN ROTATED OUT OF POSITION CAUSING THE SET SCREW TO BIND IN THE GROOVE THUS MAKING THE SURGEON APPLY EXCESSIVE FORCE TO ADVANCE THE COLLAR. THESE PLIERS WERE MANUFACTURED IN 2002 AND PROBABLY HAVE BEEN USED SEVERAL TIMES. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN PERSPECTIVE AS THERE IS NO WAY OF KNOWING HOW MUCH FORCE WAS BEING USED PER THE COMPLAINT DESCRIPTION DURING IMPACTION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A REVISION TO 1-LEVEL LUMBAR FUSION TO REMOVE NON-SYNTHES HARDWARE. DURING THE REVISION, THE SURGEON USED A 388.509 PERSUADER TO CAPTURE THE ROD, AND THE SLEEVE OF THE PERSUADER THAT HOLDS THE COLLAR BROKE WHEN IMPACTING THE COLLAR. THE BROKEN FRAGMENTS WERE REMOVED FROM THE WOUND. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142562 ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS HTC SYNTHES MONUMENT A7LA25

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR