BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 3072517 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01870
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATED THE FOLLOWING: THE IMPACTOR IN QUESTION WAS FORWARDED TO THE RESPONSIBLE PRODUCT MANAGER FOR INVESTIGATION. HE DID PERFORM A FUNCTION TEST WITH THE IMPACTOR AND THE DEVICE WAS FUNCTIONAL AS REQUIRED. HE WAS NOT ABLE TO REPRODUCE THE COMPLAINED MALFUNCTION. THIS DEVICE WAS MANUFACTURED IN SEPTEMBER 2006, ACCORDING TO THE SPECIFICATIONS. THE STRONG STRESS MARKS ON THE SHAFT AND THE HEAVY HAMMERING MARKS ON THE TOP AND THE BOTTOM OF THE HANDLE INDICATE THAT THIS WAS AN OFTEN AND INTENSE USED INSTRUMENT. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNSPECIFIED DATE, IT WAS REPORTED IT WAS NOT POSSIBLE TO ATTACH THE BLADE TO THE IMPACTOR FOR PFNA BLADE INSTRUMENT. REPORTEDLY THERE WAS NO CONSEQUENCE ON THE PATIENT, THE DELAY OF SURGERY WAS LESS THAN 20%, AND THE INCIDENT DID NOT REQUIRE FURTHER TREATMENT. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175338 IMPACTOR F/PFNA BLADE LXH SYNTHES GMBH 2212668

    Patients

    Seq Age Sex Outcome Treatment
    1