BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR PLATE,STANDARD,T-SHAPE,SHORT

    MDR report key: 7242326 · Received February 5, 2018

    Report

    Report Number
    0008010177-2018-00008
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 8, 2018
    Report Date
    July 17, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    DZE
    PMA / PMN Number
    K041651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE ANCHOR PLATE HAS NOT BEEN RETURNED, THE INTRAOPERATIVE PLATE BREAKAGE COULD BE CONFIRMED BASED ON THE EVENT DESCRIPTION AND THE PROVIDED IMAGE. ADDITIONAL INFORMATION WAS REQUESTED. THE ONLY INFORMATION THAT HAS BEEN RECEIVED THROUGH EMAIL WAS THAT THE FORCEPS USED TO BEND THE PLATE DURING THE CASE WAS A MOSQUITO FORCEPS. FIGURE 1 ILLUSTRATES THE BROKEN PLATE, THUS PLATE BREAKAGE COULD BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION ON HAND, THE USED FORCEPS IS MOST LIKELY THE HALSTEAD MOSQUITO (32-01007; FIG. 2). THE FORCEPS IS ILLUSTRATED IN THE BROCHURE (LEIBINGER INSTRUMENTS CRANIOMAXILLOFACIAL SURGERY; 90-01100; 2007) AS A NEEDLE HOLDER AND IS NOT DESIGNED FOR BENDING THE AFFECTED PLATE. IT HAS A CURVED JAW WITH A SERRATED WORKING SURFACE, THAT DEFORMS/DAMAGES THE PLATE DURING BENDING AND CREATES PREDETERMINED BREAKING POINTS. THUS, THE FORCEPS IS NOT APPROPRIATE TO BE USED AS A BENDER WITH THE ANCHOR PLATE IN QUESTION. IN SUM, BECAUSE THE SURGEON HAS USED THE MOSQUITO FORCEPS TO BEND THE AFFECTED PLATE, THE ROOT CAUSE FOR THE PLATE BREAKAGE CAN BE ATTRIBUTED TO AN OFF LABEL USE OF THE ABOVE MENTIONED FORCEPS. BASED ON THIS EVALUATION, THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT AN ANCHOR PLATE HAD BROKE INTRAOPERATIVELY DURING A PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT AN ANCHOR PLATE HAD BROKE INTRAOPERATIVELY DURING A PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86624 ANCHOR PLATE,STANDARD,T-SHAPE,SHORT IMPLANT DZE STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1