BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSUADER

    MDR report key: 5865525 · Received August 10, 2016

    Report

    Report Number
    3003875359-2016-10439
    Event Type
    Malfunction
    Date Received
    August 10, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 25, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: ONE (1) PERSUADER (PART: 03.614.027 / LOT: 8172185) WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE PERSUADER IS A COMPONENT OF THE SYNAPSE SYSTEM AND IS SPECIFICALLY UTILIZED TO REDUCE THE ROD INTO THE SCREW HEAD DURING CONSTRUCT ASSEMBLY. UPON INSPECTION OF THE DEVICE, IT CAN BE SEEN THAT THE INSTRUMENT DOES NOT OPERATE SMOOTHLY AS INTENDED. ONCE THE TRIGGER IS ENGAGED, IT WILL NOT RETURN TO THE STARTING POSITION WITHOUT SOME RESISTANCE. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION. THE COMPLAINT IS CONFIRMED. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION). THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, THE COMPLAINT CONDITION IS MOST OFTEN ASSOCIATED WITH A LACK OF LUBRICATION BETWEEN STERILIZATIONS, WHICH CAN CAUSE THE INSTRUMENT TO BIND AND BECOME DIFFICULT TO OPERATE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. UPDATED DEVICE HISTORY RECORD REVIEW BASED UPON CORRECTED LOT NUMBER: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: NOVEMBER 22, 2012. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. DEVICE 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: FEBRUARY 05, 2013. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED DURING A CERVICAL SPINE FUSION SURGERY ON (B)(6) 2016 THAT A PERSUADER DID NOT WORK SMOOTHLY AND FORCED THE SURGEON TO OPEN IT BY HAND RATHER THAN AUTOMATICALLY. IT DOES NOT RE-OPEN ONCE THE HANDLE IS SQUEEZED. THERE WAS NO DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518432 PERSUADER MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8172185

    Patients

    Seq Age Sex Outcome Treatment
    1