BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3173964 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03438
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    June 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ACTUAL EVENT DATE NOT KNOWN. 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 SCREWDRIVER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AND THE DEVICE HISTORY RECORD WAS RESEARCHED AND NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. IT IS CLEARLY VISIBLE THAT THE TIP WAS STRONGLY TWISTED BEFORE IT BROKE. THIS FINDING IS A CLEAR INDICATION THAT TOO MUCH TORQUE WAS APPLIED ONTO THIS INSTRUMENT DURING TIGHTENING A SCREW. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE INVESTIGATION FINDINGS REVEALED THAT TOO MUCH TORQUE WAS APPLIED ONTO THIS INSTRUMENT DURING THE TIGHTENING OF A SCREW. 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 TIP BROKE OFF. AN INVESTIGATION INTO THE DAMAGE HAS BEEN REQUESTED. THE DEVICE WAS PURCHASED IN (B)(6) 2010. 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
    274296 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3517619

    Patients

    Seq Age Sex Outcome Treatment
    1