BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP BEND-IRON F/RECOPL

    MDR report key: 3181024 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03739
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 21, 2011
    Report Date
    August 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE BROKEN PART WAS RETRIEVED AND ALSO RETURNED. THE INVESTIGATION OF THE COMPLAINED BENDING IRON SHOWED THAT THE POSITIONING PIN IS BROKEN OFF DUE TO MECHANICAL OVERLOADING. THE BREAKAGE SURFACE ITSELF IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. WE CAN ONLY ASSUME THAT THE PLATE WAS NOT POSITIONED CORRECTLY DURING INSERTION AND THE APPLIED MECHANICAL FORCE TO THE BENDING IRON WHILE BENDING THE PLATE RESULTED IN THE BREAKAGE OF THE POSITIONING PIN OF THE BENDING IRON. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. THIS INSTRUMENT IS NEARLY 10 YEARS OLD. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO PRODUCT FAULT COULD BE DETECTED. AS IT IS ASSUMED THAT THE APPLIED MECHANICAL FORCE TO THE BENDING IRON WHILE BENDING THE PLATE RESULTED IN THE BREAKAGE OF THE POSITIONING PIN, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POSITIONING PIN OF THE BENDING IRON IS BROKEN OFF. THE BROKEN PART WAS RETRIEVED AND RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280807 LCP BEND-IRON F/RECOPL HXP SYNTHES GMBH 2022863

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR