BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER GUIDE F/TEN

    MDR report key: 3891347 · Received June 24, 2014

    Report

    Report Number
    3003875359-2014-10185
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE REPORTED AS OVERUSED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    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 EXCEEDINGLY APPLIED MECHANICAL FORCE. IT APPEARS THAT THE THREAD WAS NOT SCREWED IN FAR ENOUGH AND WAS 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 THAT THE DEVICE WAS OVERUSED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367750 HAMMER GUIDE F/TEN HAMMER,SURGICAL FZY SYNTHES HAGENDORF 8070954

    Patients

    Seq Age Sex Outcome Treatment
    1