BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER GUIDE FOR TI ELASTIC NAILS

    MDR report key: 3884151 · Received June 19, 2014

    Report

    Report Number
    3003875359-2014-10180
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION HAS SHOWN THAT THE THREAD OF THE HAMMER GUIDE IS INDEED BADLY DAMAGED DUE TO EXCEEDING APPLIED MECHANICAL FORCE. IT APPEARS THAT THE THREAD WAS NOT SCREWED IN FAR ENOUGH AND GOT DAMAGED DURING USE. ALSO THE MARKS FOUND ON THE HEAD OF THE GUIDE GIVE US AGAIN A CLEAR INDICATION THAT THE SLOTTED HAMMER HAS NOT BEEN USED ACCORDINGLY, WHICH IS CONSIDERED AS A HANDLING FAULT. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLE IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. 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 DURING THE OPERATION THE THREADED END OF THE DEVICE CAME OFF. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361362 HAMMER GUIDE FOR TI ELASTIC NAILS HAMMER,SURGICAL FZY SYNTHES HAGENDORF 1911775

    Patients

    Seq Age Sex Outcome Treatment
    1