BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL

    MDR report key: 3818855 · Received May 19, 2014

    Report

    Report Number
    2520274-2014-11527
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMANCE 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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE; AS RECEIVED CONDITION OF DEVICE PART WAS RECEIVED BROKEN AND INVESTIGATION OF THE RETURNED UNIT CONFIRMS THAT THE BOTTOM OF THE CUTTING HEAD IS INDEED BROKEN OFF. A REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS (MANUFACTURED IN FEBRUARY 2009). UNFORTUNATELY THE SCHANZ SCREW WAS NOT RETURNED IN ORDER TO UNDERSTAND THE MENTIONED PROBLEM. 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. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 EUROPE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE BOLT CUTTING HEAD BROKE WHILE TRIMMING A SCREW. THE SURGEON USED A JUMBO CUTTER INSTEAD AND COMPLETED THE OPERATION; THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE. THE TRIMMED SCREW HAD BURRS ON THE CUT SURFACE AND HIGHER PROFILE THAN NORMAL. THERE WAS NO REPORTED PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297160 BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL CUTTER, WIRE HXZ SYNTHES HAGENDORF 3058854

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR