BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED PERSUADER-STANDARD

    MDR report key: 3690639 · Received March 20, 2014

    Report

    Report Number
    3003875359-2014-10032
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE THREADED PERSUADER (03.632.408 LOT 7943913) IS A COMPONENT OF THE MATRIX SET FOR ROD REDUCTION ((B)(4)). THE MATRIX SPINE SYSTEM ¿ DEGENERATIVE IS A ¿COMPREHENSIVE THORACOLUMBAR PEDICLE SCREW SYSTEM DESIGNED TO PROVIDE FLEXIBILITY, BIOMECHANICAL PERFORMANCE AND A TOTAL SOLUTION TO COMPLEX POSTERIOR PATHOLOGICAL CHALLENGES.¿ THE THREADED PERSUADER IS SPECIFICALLY USED TO AID IN THE REDUCTION OF THE ROD. THE PERSUADER IS POSITIONED ABOVE THE IMPLANT, BEING SURE TO ALIGN THE INNER REDUCTION TUBE SLOTS OVER THE ROD. ONCE LINED UP, THE PERSUADER CAN BE PRESSED ONTO THE SCREW HEAD AND THE ROD CAN BE REDUCED THROUGH THE USE OF A HEX DRIVE ADAPTER. FINALLY A LOCKING CAP CAN BE INSERTED AND TIGHTENED, WITH THE PERSUADER ACTING AS A COUNTERTORQUE (MATRIX DEGENERATIVE TECHNIQUE GUIDE (B)(4)).DRAWINGS FOR THE THREADED PERSUADER WERE REVIEWED: SPECIFICALLY THOSE RELATED TO THE REDUCTION TUBE ASSEMBLY ((B)(4)), THE REDUCTION INSERT ((B)(4)), THREADED TUBE ((B)(4)) AND THE ASSEMBLY ((B)(4)). THESE DRAWINGS WERE FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE RETURNED COMPONENTS OF THE PERSUADER (REDUCTION TUBE ASSEMBLY AND THREADED TUBE) WERE FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. THE PRODUCT WAS RECEIVED UNDER THE COMPLAINT CONDITION ¿BROKEN: INTRAOPERATIVELY.¿ THE RETURNED COMPONENTS SHOW NO APPARENT SIGNS OF FAILURE. THE COMPLAINT DESCRIPTION SIMPLY STATES: ¿THE THREADED PERSUADER SNAPPED OFF USING MATRIX SYSTEM¿. AS MORE DETAILS AS TO THE SPECIFICS OF THE FAILURE WERE NOT PROVIDED AND AS THE REMAINING COMPONENTS OF THE INSTRUMENT WERE NOT RETURNED, IT IS NOT POSSIBLE TO ACCURATELY ESTABLISH THE FAILURE MODE OR CAUSE. THE INSTRUMENT COMPONENTS WHICH WERE RETURNED ARE IN GOOD CONDITION WITH NO APPARENT DEFECTS. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. AS FULL DETAILS AS TO THE FAILURE AND THE CIRCUMSTANCES WHICH BROUGHT IT ABOUT WERE NOT ADEQUATELY PROVIDED AND AS COMPONENTS OF THE INSTRUMENT WERE NOT RETURNED, IT IS NOT POSSIBLE TO IDENTIFY A FAILURE MODE OR CAUSE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO NCRS GENERATED DURING PRODUCTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6) REPORTED: DURING A LOW BACK FUSION (MIS-MINIMALLY INVASIVE SPINE SURGERY) THE THREADED PERSUADER SNAPPED OFF USING THE MATRIX SYSTEM. THE SURGERY WAS COMPLETED USING A SIMILAR INSTRUMENT. THERE WAS NO REPORTED DELAY TO THE SURGERY DUE TO THE COMPLAINED EVENT. THERE WAS NO REPORTED PATIENT HARM NOTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167574 THREADED PERSUADER-STANDARD MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 7943913

    Patients

    Seq Age Sex Outcome Treatment
    1