BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3223468 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-03530
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PART WAS ADDED ON (B)(4) 2013; AWARENESS DATE OF THE ADDITIONAL PART WAS (B)(4) 2013. 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS PERFORMED BY SYNTHES (B)(4) AND THE REPORT INDICATES: OUR INVESTIGATION HAS SHOWN THAT THE T-HANDLE OF THE RETURNED INSERTER IS INDEED BROKEN OFF. IT IS CLEARLY VISIBLE THAT THE TOP OF THE INSERTER AS WELL AS THE SURFACE OF THE T-HANDLE HAVE BEEN STRUCK WITH HEAVY HAMMER BLOWS. BASED ON THESE FINDINGS, EXCESSIVE USE CAUSED THE MALFUNCTION OF THIS DEVICE. IN THIS RELATION WE WOULD LIKE TO MENTION PAGE 20 OF THE TECHNIQUE GUIDE WHERE IT IS STATED THAT JUST GENTLE BLOWS SHOULD BE APPLIED ONTO THE IMPACTION SURFACE OF THE INSERTER AND THAT BLOWS ON THE T-HANDLE SHOULD BE AVOIDED. IF HIGHER FORCES ARE NECESSARY THE HAMMER GUIDE (359.218) CAN BE USED. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLE IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED .

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY, A NAIL WAS BEING INSERTED USING RECON SCREWS. THE DISTAL GUIDE WIRE WAS INSERTED FIRST. IT WAS SITTING OFF CENTER IN THE HOLE OF THE NAIL. THE PROXIMAL GUIDE WIRE MISSED THE NAIL COMPLETELY. THE SURGEON USED THE REAMER TO DRILL THE NAIL. THE RECON SCREWS WERE NOT SITTING PARALLEL TO EACH OTHER. THIS IS REPORT 5 OF 5 FOR THE SAME EVENT, (B)(4).

    Description of Event or Problem · 1

    THIS IS 5 OF 5 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321653 INSERTER F/TEN LXH SYNTHES GMBH 3318766

    Patients

    Seq Age Sex Outcome Treatment
    1