BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XRL RELEASE TOOL

    MDR report key: 3083480 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11165
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    PMA / PMN Number
    K103320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING VISUAL EVALUATION NOTED THE KNOB AND THE SHAFT WERE SEPARATED, AND THE WELD WAS BROKEN. THE RELEVANT DIMENSION OF THE KNOB HOLE CAN NOT BE VERIFIED ANY LONGER DUE TO THE BROKEN WELD. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE FRACTURE FACE OF THE WELD IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AND IS UNIFORM WHICH INDICATES THAT THE WELD WAS CARRIED OUT PROPERLY. PRODUCT DEVELOPMENT EVALUATION NOTED THAT THE KNOB OF THE RELEASED TOOL WAS SEPARATED FROM THE SHAFT. WELDING MATERIAL REMAINED ON BOTH THE KNOB AND THE SHAFT. MILD ABRASION WAS NOTED WHERE THE RELEASE TOOL KNOB SITS IN THE SPREADER. THE RELEASE TOOL IS PART OF THE XRL SPREADER ASSEMBLY AND HAS BEEN SUBJECTED TO EXCESSIVE HAMMERING WELL BEYOND ITS INTENDED USE. THIS IS CONFIRMED BY THE UPDATED COMPLAINT INFORMATION PROVIDED BY A CONVERSATION WITH THE SALES PERSONNEL PRESENT DURING THE CASE. THE SURGICAL TECHNIQUE GUIDE HAS A BOLD FONT WARNING WHICH STATES ON PAGE 18 NOT TO IMPACT ON THE SPREADER. IN ADDITION TO NOT FOLLOWING THE TECHNIQUE, THE SURGEON EXCESSIVELY HAMMERED ON THE DEVICE SEVERAL TIMES. HAMMERING IS CLEARLY OUTSIDE OF THE TECHNIQUE GUIDANCE FOR THIS DEVICE. BASED ON THESE TWO FACTORS THE COMPLAINT IS DEEMED INVALID.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A CORPECTOMY PROCEDURE, THE SURGEON HAMMERED ON THE XRL SPREADING AND THE WELDING UNDERNEATH THIS RELEASE TOOL CAME OFF AT THE END OF THE PROCEDURE, . ALL PIECES WERE RETRIEVED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT OR ADVERSE EVENT TO HE PATIENT WAS NOTED. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183859 XRL RELEASE TOOL MQP SYNTHES GMBH 7887173

    Patients

    Seq Age Sex Outcome Treatment
    1