BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/UFN/CFN

    MDR report key: 3171108 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03319
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    July 10, 2012
    Report Date
    July 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE COMPLAINED INSERTION HANDLE SHOWS THAT BOTH NAIL POSITIONING PINS ARE INDEED COMPLETELY BROKEN OFF. WE CAN ONLY SUPPOSE THAT TOO MUCH MECHANICAL FORCE OR OVERLOAD DURING THE INTERNAL ROTATION MAY HAVE LED TO THE BREAKAGES OF THE TWO PINS. 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. NO PRODUCT FAULT COULD BE DETECTED AND THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE SUPPOSE THAT TOO MUCH MECHANICAL FORCE OR OVERLOAD DURING THE INTERNAL ROTATION MAY HAVE LED TO THE BREAKAGES OF THE TWO PINS. THEREFORE, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND THE OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. NOTE: IT IS RECOMMENDED TO USE THIS INSTRUMENT ACCORDING TO THE GIVEN SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY. AFTER INSERTING THE NAIL FULLY, THE SURGEON NEEDED TO CHANGE THE POSITION OF THE RECON SCREWS IN THE FEMORAL NECK. WHEN APPLYING AN INTERNAL ROTATION FORCE BY LIFTING THE HANDLE, THE TWO LUGS SHEARED OFF THE NAIL - HANDLE INTERFACE. DOCTOR SAID THAT HE HAD REAMED 1.5 MM ABOVE THE NAIL DIAMETER AND HAD USED THE APPROPRIATE OPENING REAMER FOR A 12 MM NAIL. NO FURTHER INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270305 INSERT-HANDLE F/UFN/CFN LXH SYNTHES GMBH 3009845

    Patients

    Seq Age Sex Outcome Treatment
    1