BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 3840433 · Received May 30, 2014

    Report

    Report Number
    3003875359-2014-10150
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 2, 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE KNOB IS MISSING, NO INVESTIGATION ON THIS ARTICLE CAN BE DONE. AFTER LUBRICATION OF THE RETURNED ITEMS THE FRICTION WAS REDUCED THIS IS A CLEAR INDICATION THAT THE DEVICE WAS NOT MAINTAINED PROPERLY. ACCORDING TO THE SURGICAL TECHNIQUE AND THE EXISTING DOCUMENTS THE DEVICE NEEDS TO BE DISASSEMBLED PRIOR TO CLEANING AND STERILIZATION AND LUBRICATION WITH SYNTHES OIL SHOULD BE DONE. 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

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING THE PROCEDURE THE APPLICATOR HANDLE KNOB COULD NOT BE TURNED COUNTER-CLOCKWISE ALTHOUGH THE SECURITY-RING WAS PULLED DOWN AS REQUIRED TO DETACH THE IMPLANT. AFTER TURNING LEFT AND RIGHT SEVERAL TIMES THE DEVICE WORKED. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318705 T-PAL SPACER APPLICATOR INNER SHAFT MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8748378

    Patients

    Seq Age Sex Outcome Treatment
    1