BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3171567 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03396
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    September 19, 2011
    Report Date
    September 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. (B)(6). 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 BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF THE FAILURES IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND WE SUPPOSE THAT TOO MUCH TORQUE WAS APPLIED ONTO THE INSTRUMENT DURING TIGHTENING. 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 RESULTS SHOW EVIDENCE THAT TOO MUCH TORQUE WAS APPLIED ONTO THE INSTRUMENT DURING TIGHTENING. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. PLEASE NOTE THAT OUR PROJECT MANAGER HAS DECIDED TO TAKE A CLOSER LOOK AT THE DESIGN IN ORDER TO AVOID PROBLEMS LIKE THIS IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF DURING FINAL TIGHTENING. UNFORTUNATELY THE BROKEN TIP HAS BEEN PUT INTO THE GARBAGE AND WE DO NOT HAVE ANY ACCESS TO IT. 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
    272594 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3231877

    Patients

    Seq Age Sex Outcome Treatment
    1