BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD-INTRODUCTPLIERS LONG F/MATRIX 5.5

    MDR report key: 3173962 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03414
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVALUATION HAS SHOWN THAT THE INSTRUMENT HAD INDEED JAMMED UP. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE CAUSE WHICH HAS LED TO THIS PROBLEM. WE CAN ONLY SUPPOSE THOUGH THAT THE PLIERS HAD BEEN COMPRESSED IN SUCH A WAY THAT IT COULD NOT BE LOOSENED ANYMORE AND COMPLETELY JAMMED UP. 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. BASED ON THE INVESTIGATION FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE HAND JAMMED AND WOULD NOT COME FREE. 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
    273806 ROD-INTRODUCTPLIERS LONG F/MATRIX 5.5 LXH SYNTHES GMBH T960066

    Patients

    Seq Age Sex Outcome Treatment
    1