BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD-INTRODUCTPLIERS F/R Ø6

    MDR report key: 3142487 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02613
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. EVENT DATE INCORRECTLY REPORTED IN INITIAL MW. INCORRECTLY REPORTED IN INITIAL MW; USAGE OF DEVICE IS UNKNOWN. PLACEHOLDER.

    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. INVESTIGATION OF THE COMPLAINED DEVICE REVEALED THAT THE TIP OF THE INSTRUMENT WAS BROKEN OFF. THE NUT IN THE BACK OF INSTRUMENT WAS ALSO DAMAGED. THE DEVICE WAS SENT TO THE REPAIR DEPARTMENT IN ORDER TO MAINTAIN/REPAIR. 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. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE TOOL BROKE OFF DURING THE INSERTION OF THE ROD. 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
    244194 ROD-INTRODUCTPLIERS F/R Ø6 HTC SYNTHES GMBH AN8773

    Patients

    Seq Age Sex Outcome Treatment
    1