BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR HANDLE

    MDR report key: 4210533 · Received October 29, 2014

    Report

    Report Number
    3003875359-2014-10344
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION FROM COMPLAINED APPLICATOR OUTER SHAFT SHOWS THAT THE THREAD PROXIMAL IS WITHOUT DAMAGES. THE APPLICATOR INNER SHAFT AND THE APPLICATOR KNOB WHICH COMPLETE THE INSTRUMENT HAS NOT RETURNED AND THEREFORE COULD NOT BE INVESTIGATED. FUNCTION FROM APPLICATOR OUTER SHAFT THREAD HAS BEEN CHECKED WITH A TEST-APPLICATOR-KNOB AND HAS BEEN CONFIRMED. THEREFORE WE CANNOT CONFIRM THE REPORTED EVENT. THE TIP DISTAL FROM APPLICATOR OUTER SHAFT SHOWS DAMAGES FOR THE POSSIBILITY THAT THIS COULD LEAD INTO A JAMMED APPLICATOR INNER SHAFT AND APPLICATOR KNOB TOO. AFTERWARDS AND WITHOUT FURTHER DETAILS AND WITH AN INCOMPLETE INSTRUMENT IT IS UNFORTUNATELY NOT POSSIBLE TO DETERMINE THE EXACT CAUSE WHICH INDUCE THE TIP DAMAGE DISTAL. AN UNFORESEEN MECHANICAL FORCE CAUSED A MATERIAL FATIGUE AND THIS LEAD INTO THE DAMAGE OF THE TIP DISTAL. FURTHER INVESTIGATION OF DOCUMENTATION FOR MATERIAL AND MANUFACTURING SHOWS THAT THE APPLICATOR OUTER SHAFT HAS BEEN PRODUCED IN MAY 2014 UNDER SPECIFICATION. NO FAILURE IN MATERIAL OR MANUFACTURING COULD BE DETECTED. 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 THAT THE THREAD AT THE PROXIMAL TIP DOES NOT FIT PROPERLY WITH THE THREAD FROM KNOB. THE PARTS ARE JAMMING WHEN TRYING TO BE USED. THIS OCCURRED DURING A PROCEDURE, BUT THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692295 T-PAL SPACER APPLICATOR HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8932963

    Patients

    Seq Age Sex Outcome Treatment
    1