BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL TRIAL SPACER 10MM X 28MM 13MM HEIGHT

    MDR report key: 3920186 · Received July 8, 2014

    Report

    Report Number
    3003875359-2014-10197
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE PARTS WERE MADE TO (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RELEVANT DIMENSION OF THE COUPLING PART CANNOT BE MEASURED DUE TO ITS BROKEN OFF CONDITION. THE RELEVANT FEATURE CANNOT BE MEASURED ACCURATELY. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. NO NCRS 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. 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 OF THE TRIAL IMPLANT THE BALL-TIP AT THE BACK OF THE TRIAL IMPLANT THAT IS IN THE APPLICATOR KNOB BROKE OFF. THE PART STAYED STUCK IN THE APPLICATOR KNOB AND THE MECHANISM WAS LOCKED DUE TO THAT PART. NO PATIENT HARM AND PROLONGATION OF SURGERY AS THERE WAS A SECOND INSTRUMENT AVAILABLE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397213 T-PAL TRIAL SPACER 10MM X 28MM 13MM HEIGHT TEMPLATE HWT SYNTHES HAGENDORF 7599337

    Patients

    Seq Age Sex Outcome Treatment
    1