BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/

    MDR report key: 3162582 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03043
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE BODY OF THE CUTTING HEAD IS BROKEN OFF. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. PLEASE NOTE IT IS VERY IMPORTANT THAT THE SCHANZ SCREW IS POSITIONED CORRECTLY BEFORE CUTTING AND THAT VERY FAST CUTTING-PROCEDURES MAY LEAD TO A SHORT TIME OVERLOADING RESULTING IN THE BREAKAGE OF THE BOTTOM OF THE CUTTING HEAD. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE BOLT CUTTER WAS BROKEN. THE PATIENT HAD A COMPRESSED FRACTURE OF TH12. AFTER THE FINAL FIXING, THE SURGEON TRIED TO CUT THE SCREW, THE BOLT CUTTER WAS BROKEN. FIVE OF SIX SCREWS WERE CUT WITHOUT ANY PROBLEM, HOWEVER THE CUTTER WAS BROKEN AT THE SIXTH ONE. THE SURGEON COULD NOT CUT THE SCREW, SO HE CUT IT BY USING HP PIN CUTTER. IT TOOK A LONGER TIME, BECAUSE IT WAS NOT A DEDICATED INSTRUMENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262785 BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/ HXZ SYNTHES GMBH 3792924

    Patients

    Seq Age Sex Outcome Treatment
    1