BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLTCUTTER

    MDR report key: 6332142 · Received February 15, 2017

    Report

    Report Number
    9680938-2017-10021
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Report Date
    January 18, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    UDI-DI
    07611819710504
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (BOLTCUTTER, PART NUMBER 388.720, LOT NUMBER T112808). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE CUTTING EDGE OF THE BOLT CUTTER IS BADLY DAMAGED. SOME ROUND SHAPED PIECES AT BOTH JAWS OF THE BOLT CUTTER ARE BROKEN OFF. THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN NOVEMBER 2014 ACCORDING TO THE SPECIFICATIONS. THE COMPONENT PARTS AS WELL AS THE FINAL PRODUCT PASSED INSPECTION REQUIREMENTS. IN ADDITION, ALL 50 PARTS OF THE PRODUCTION LOT WERE CHECKED PER 100% FOR IMPORTANT FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION, NO DEVIATIONS WERE NOTED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO INFORMATION ABOUT THE CUTTING PROCEDURE WAS PROVIDED; THEREFORE, THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED. HOWEVER, DUE TO PREVIOUSLY RECEIVED MARKET FEEDBACK THE FAILURE OF THIS OCCURRENCE HAS BEEN IDENTIFIED; SUCH DAMAGE TO THE CUTTING EDGE COULD ONLY BE IMITATED BY CUTTING AN EXTRA-HARD COBALT-CHROMIUM ROD. IN THIS REGARD WE WOULD LIKE TO POINT OUT THAT THIS DEVICE IS NOT SUITABLE FOR CUTTING COBALT-CHROMIUM ALLOYS. FOR CUTTING THIS KIND OF RODS THE USS ROD CUTTING AND BENDING DEVICE (ART. 388.750) MUST BE USED. THE TYPE AND EXTENT OF DAMAGE INCURRED INDICATE THAT THIS COMPLAINT WAS CAUSED BY WRONG HANDLING. 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

    IT IS UNKNOWN WHEN THE DEVICE BROKE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 388.720, LOT# T112808. THE WORK ORDER WAS DIVIDED INTO THREE PARTIAL LOTS. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: NOV 21, 2014, ADDITIONAL MANUFACTURING DATES: FEB 26, 2015 AND DEC 16, 2015. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2017, IT WAS DETECTED AT THE DISTRIBUTOR, BEFORE THE SURGERY, THAT THE ROD CUTTER WAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. IT IS UNKNOWN HOW AND WHEN THE DEVICE BROKE. UPON THE RECEIPT OF THE DEVICE AT MANUFACTURER, IT WAS CONFIRMED THAT THE EDGE OF THE ROD CUTTER IS BADLY DAMAGED, AND THE ROUND SHAPED PIECES AT BOTH JAWS ARE BROKEN OFF. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116412 BOLTCUTTER CUTTER, WIRE HXZ SYNTHES TUTTLINGEN T112808 07611819710504

    Patients

    Seq Age Sex Outcome Treatment
    1