BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/

    MDR report key: 3042697 · Received April 9, 2013

    Report

    Report Number
    8030965-2013-01500
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ADDITIONAL PRODUCT CODES: HTZ, FZT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE MANUFACTURING DOCUMENTS WHERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHEN THE SURGEON WAS CUTTING THE IMPLANT, THE TIP BROKE OFF ON THE BOLT CUTTING HEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145395 BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/ HXZ SYNTHES GMBH 3647791

    Patients

    Seq Age Sex Outcome Treatment
    1