BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3072957 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01876
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PERFORMED INVESTIGATION OF THE INSTRUMENT SHOWS SIGNIFICANT METALLIC SPLINTERS AT THE AREA OF THE CANNULATION. WE ASSUME THAT VIOLENTLY HAMMERING WAS LEADING TO STRAIN HARDENING. THIS PREFERS THE FORMATION OF CHIPPING. SUBSEQUENTLY CUT MARKS WERE RECOGNIZED AT THE PIVOTED LEVER. WE CONCLUDE THERE WAS A DIRECT IMPACT OF PERCUSSION. IN THIS CONTEXT WE WOULD LIKE TO REFER TO OUR OP TECHNIQUE. DIRECT IMPACT ON THE T-PIECE IS TO BE PREVENTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE METAL CHIPS ON THE INSERTER FOR ELASTIC NAILS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173381 INSERTER F/TEN LXH SYNTHES GMBH 3697518

    Patients

    Seq Age Sex Outcome Treatment
    1