BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL

    MDR report key: 4222799 · Received November 4, 2014

    Report

    Report Number
    3003875359-2014-10354
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HTZ AND FZT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT: THE BOTTOM OF THE CUTTING HEAD IS BROKEN APART AS COMPLAINED. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED IN DECEMBER 2005 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON OF THIS FRACTURE. WE ASSUME THAT IT¿S A NORMAL WEAR AND TEAR OVER THE YEARS, AS THE INSTRUMENT IS ALMOST 9 YEARS OLD. PLEASE NOTE IT IS VERY IMPORTANT THAT THE SCHANZSCREW 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. IN ADDITION THIS INSTRUMENT IS SUBJECTED TO COMMON WEAR AND TEAR AND AS SOON AS THE CUTTING PROCEDURE GETS HARDER IT MAY BE INDICATED THAT THE DEVICE SHOULD BE REPLACED. 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 SURGEON USED SCHANZ FOR THE SURGERY OF A THORACOLUMBAR BURST FRACTURE. THE SURGEON CUT THE SCREW AFTER THE COMPLETE FIXATION OF THE CONNECTOR NUT. DURING THE CUTTING OF THE SECOND SCREW FOR L1, THE BOLT CUTTER ROOT BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGICAL DELAY WAS TEN MINUTES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706766 BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL CUTTER, WIRE FZT SYNTHES HAGENDORF 1424991

    Patients

    Seq Age Sex Outcome Treatment
    1