BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 4731308 · Received April 27, 2015

    Report

    Report Number
    3003875359-2015-10188
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Report Date
    April 12, 2015
    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: MANUFACTURING INVESTIGATION EVALUATION: RECEIVED 1 ARTICLE OF APPLICATOR KNOB, PART #03.812.004 FOR MANUFACTURING INVESTIGATION. THE ARTICLE HAS NO VISIBLE DAMAGE. AFFECTED PART - PART DESCRIPTION: APPLICATOR KNOB; PART NUMBER: 03.812.004; LOT NUMBER: 9020683; LOT SIZE: (B)(4) PIECES; LOT RELEASE DATE: AUGUST 14, 2014; REPORTED ISSUE. DURING SURGERY, THE TPAL INSERTER JAMMED AND THE IMPLANT COULD NOT BE RELEASED. THERE IS A GRINDING NOISE WHEN THE INSERTER IS TURNED FROM OPEN TO CLOSE AND IT SEEMS TO BE STICKING. IT IS NOT KNOWN IF THE HANDLE OR THE KNOB IS FAULTY. CONCLUSION: DURING MANUFACTURING INVESTIGATION ALL RELEVANT AND SIGNIFICANT CHARACTERISTICS LIKE DIMENSIONS WERE CHECKED AND ADDITIONALLY FUNCTIONAL TESTS WERE PERFORMED. ALL CHECKED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS AND THE ARTICLE PASSED ALL FUNCTIONAL TESTS. IT WAS FOUND NO GRINDING NOISE DURING THE FUNCTIONAL TESTS. THE NOISE, AS DESCRIBED IN THE COMPLAINT, COULD BE CAUSED BY INADEQUATE LUBRICATION. ACCORDING TO THE TECHNIQUE GUIDE (CLEANING AND STERILIZATION INSTRUCTIONS), DISMANTABLE THREADED CONNECTIONS MUST BE REGULARLY LUBRICATED. 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

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL CONTACT NAME: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 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

    UPDATE: IT WAS REPORTED THAT THERE WAS A TWO TO THREE MINUTE DELAY IN THE PROCEDURE WHILE THE SURGEON ATTEMPTED TO DISENGAGE THE INSTRUMENT.

    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 SURGERY, THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBER (TPAL) INSERTER JAMMED AND THE IMPLANT COULD NOT BE RELEASED. THERE IS A GRINDING NOISE WHEN THE INSERTER IS TURNED FROM OPEN TO CLOSE AND IT SEEMS TO BE STICKING. IT IS NOT KNOWN IF THE HANDLE OR THE KNOB IS FAULTY. THERE WAS NO PATIENT HARM REPORTED. THERE WAS A TWO TO THREE MINUTE DELAY IN THE PROCEDURE. THERE WAS ANOTHER ONE AVAILABLE TO USE DURING THE PROCEDURE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276784 T-PAL SPACER APPLICATOR KNOB MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 9020683

    Patients

    Seq Age Sex Outcome Treatment
    1