BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP BEND-IRON F/RECOPL

    MDR report key: 3170233 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03217
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    November 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE ADDITIONAL EVALUATION REVEALED THAT THE INVESTIGATION OF THE COMPLAINED BENDING IRON SHOWED THAT ONE POSITIONING PIN IS INDEED BROKEN OFF DUE TO MECHANICAL OVERLOADING. THE BROKEN SURFACE ITSELF IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. WE CAN ONLY ASSUME THAT THE PLATE WAS NOT INSERTED AND POSITIONED CORRECTLY. THE APPLIED MECHANICAL FORCE RESULTED IN THE BREAKAGE OF THE PIN. PLEASE NOTE THAT THIS INSTRUMENT IS SEVERAL YEARS OLD (2005). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PEG OF THE PLATE BENDER BROKE OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272221 LCP BEND-IRON F/RECOPL HXP SYNTHES GMBH 2125945

    Patients

    Seq Age Sex Outcome Treatment
    1