BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER GUIDE FOR TI ELASTIC NAILS

    MDR report key: 4141478 · Received October 4, 2014

    Report

    Report Number
    3003875359-2014-10296
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE INVESTIGATION HAS SHOWN THAT THE THREAD OF THE HAMMER GUIDE IS BROKEN OFF. ALSO EXTENSIVE MARKS FOUND ON THE HEAD. FURTHER INVESTIGATION SHOWED CONFORMITY. THE INSTRUMENT WAS PRODUCED TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. THE CONDITION OF THE HAMMER GUIDE GIVES EVIDENCE THAT DUE TO EXCEEDING APPLIED MECHANICAL FORCE RELATED TO LONG TERM USE CAUSED A COLD DEFORMATION ON THE HEAD, FOLLOWED BY MATERIAL FATIGUE DISTAL AND FINALLY THE BROKEN THREAD. DATE RECEIVED BY MFR: WAS ORIGINALLY REPORTED AS 08/09/2014, MEDWATCH WAS ORIGINALLY SUBMITTED TO THE FDA ON OCTOBER 8, 2014. ADVISED BY THE FDA ON OCTOBER 13, 2014 TO RE-SUBMIT 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 DEVICE WAS BROKEN ON THE END PRIOR TO THE SURGERY TAKING PLACE. THIS REPORT IS FOR 1 OF 1 FRO COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621691 HAMMER GUIDE FOR TI ELASTIC NAILS HAMMER, SURGICAL FZY SYNTHES HAGENDORF 1527722

    Patients

    Seq Age Sex Outcome Treatment
    1