BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER 500 GRAMS

    MDR report key: 6560285 · Received May 11, 2017

    Report

    Report Number
    9612488-2017-10211
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZY
    UDI-DI
    07611819027824
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOTS. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: OCT 31, 2005. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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. THE 1X 399.420 LOT 2101557. DHR-REVIEW SHOWED NO DEVIATION. VISUAL INSPECTION SHOWED THAT HAMMER FRONT SECTION DOES HAVE DENTS AND MARKS OF NORMAL USE. SHAFT SHOWS SCRATCHES AND ARTICLE/LOT NUMBER ARE FADING. HANDLE IS DISCOLORED AND DOES PEEL OFF. BASED ON MANUFACTURING DATE THIS ARTICLE IS OVER 11 YEAR OLD AND MUST HAVE BEEN REGULARLY USED BASED ON DETECTED DAMAGES AND WEAR MARKS. COMPLAINED ARTICLE WAS USED MANY TIMES AND A REPLACEMENT IS RECOMMENDED DUE TO WEAR AND TEAR OVER TIME. 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

    SYNTHES (B)(4) REPORTED AN EVENT (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE NURSE¿S PRE-SURGICAL INSPECTION OF SURGICAL HAMMERS TO BE USED IN SURGERY TO TREAT A LEFT FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2017, A POWDERY FOREIGN SUBSTANCE WAS OBSERVED ON THE HANDLE PORTION OF THE DEVICES. THE SYNTHES SALES REPRESENTATIVE RECOMMENDED THAT THE NURSE USE THE SYNTHES LOAN DEVICES AVAILABLE AT THE HOSPITAL INSTEAD BUT THE SAME ISSUE WAS OBSERVED ON THE HANDLES OF THE LOAN DEVICES. BECAUSE THIS EVENT WAS DISCOVERED BEFORE THE SURGERY, THE NURSE NOTIFIED THE SURGEON OF THE ISSUE. THE SURGEON OPTED TO USE THE DEVICES FOR THE SURGERY WITHOUT TAKING THEM OUT OF THE STERILIZED PACKAGING (BAGS). THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND THE SURGERY WAS COMPLETED WITHOUT DELAY. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343281 HAMMER 500 GRAMS HAMMER, SURGICAL FZY SYNTHES BETTLACH 2101557 07611819027824

    Patients

    Seq Age Sex Outcome Treatment
    1