BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN

    MDR report key: 3173940 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03412
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    September 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE UPPER PART OF THE SHORT CUT IS BROKEN AS REPORTED. THE BROKEN SURFACE OF THE INSTRUMENT IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. EVIDENCE CONCLUDES THAT DUE TO BLUNT EDGES EXCESSIVE MECHANICAL FORCE WAS APPLIED, WHICH LED TO THE BREAKAGE. 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. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE INVESTIGATION EVIDENCE CONCLUDES THAT DUE TO BLUNT EDGES EXCESSIVE MECHANICAL FORCE WAS APPLIED, WHICH LED TO THE BREAKAGE. THUS, 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 SHORTCUT BROKE DURING A WORKSHOP. 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
    274473 SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN HTZ SYNTHES GMBH 3200738

    Patients

    Seq Age Sex Outcome Treatment
    1