BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 4170518 · Received October 14, 2014

    Report

    Report Number
    3003875359-2014-10317
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE DEVICE WAS FUNCTIONAL AND WITHOUT DAMAGES. A FUNCTIONAL TEST WAS PERFORMED WHICH SHOWED THAT THE RIGIDITY OF THE IMPLANT-APPLICATOR-CONNECTION SLIGHTLY DECREASED DUE TO DEFORMED INTERFACE .THE DEFORMATION OCCURS DUE TO AN INCOMPLETE ADJUSTMENT IN THE "PIVOTING" POSITION WHICH DESCRIBED IN THE SURGICAL TECHNIQUE GUIDE (STG) ON PAGE 47. THE STG ADDITIONALLY STATES ON PAGE 17: "NOTE: ENSURE APPLICATOR KNOB IS TURNED COUNTERCLOCKWISE UNTIL IT STOPS TO AVOID TRIAL OR APPLICATOR OUTER SHAFT DEFORMATION" AND ON PAGE 27: "NOTE: ENSURE APPLICATOR KNOB IS TURNED COUNTERCLOCKWISE UNTIL IT STOPS TO AVOID DEFORMATION OF THE APPLICATOR OUTER SHAFT." INVESTIGATION OF DOCUMENTATION FOR MATERIAL AND MANUFACTURING SHOWS THAT THE INSTRUMENT COMPONENTS HAVE BEEN PRODUCED UNDER SPECIFICATION IN DECEMBER 2013 (OUTER SHAFT) AND NOVEMBER 2013 (KNOB). NO FAILURE IN MATERIAL OR MANUFACTURING COULD BE DETECTED. IT CAN BE STATED THAT A USER ERROR IS THE CLOSEST POSSIBLE ROOT CAUSE FOR THE REPORTED EVENT. 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) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE INSERTION THE TRAIL IMPLANT DID NOT REMAIN IN THE FIXED POSITION. ANOTHER AVAILABLE PART WAS PRESENT AND USED TO COMPLETE THE SURGERY. NO PATIENT HARM WAS REPORTED. THERE WAS A PROLONGED TIME OF 15 MINUTES REPORTED. THIS IS REPORT NUMBER 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651647 T-PAL SPACER APPLICATOR KNOB MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8620648

    Patients

    Seq Age Sex Outcome Treatment
    1