BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3131720 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02437
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 19, 2011
    Report Date
    January 27, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    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 FRACTURE FACE OF THE BROKEN TIP IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. 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 AND WE HAVE TO ASSUME THAT THE APPLIED MECHANICAL FORCES WERE EXCEEDED WHICH LED TO THE BREAKAGE. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THEREFORE, USER ERROR CONTRIBUTED TO THE EVENT AND THE APPLIED MECHANICAL FORCES WERE EXCEEDED WHICH LED TO THE BREAKAGE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) 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 HISTORY RECORD REPORTS THE COMPLAINT TO BE INVALID, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE FRACTURE FACE OF THE BROKEN TIP 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 AND WE HAVE TO ASSUME THAT EXCEEDING APPLIED MECHANICAL FORCES LED TO THE BREAKAGE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREW DRIVER SHAFT SHEARED OFF. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES CONSULTANT THAT THE TIP OF URS DRIVER SHEARED OFF. WHILE FINAL TIGHTENING OF THE LOCKING CAPS WITH TORQUE LIMITING HANDLE SCREW DRIVER THE TIP OF THE SCREWDRIVER BROKE INTO MULTIPLE PIECES. ALL THESE PIECES OF THE SCREWDRIVER SHAFT WERE RECOVERED FROM THE PATIENT. WHILE USING THE T25 STARDRIVE TO BACK OFF A SET SCREW, THE SHAFT BEGAN TO UNSCREW OUT OF THE GREEN T-HANDLE DROPPING RESIDUE INTO THE PATIENT. THE RESIDUE FROM THE T-HANDLE MATERIAL WAS REMOVED FROM THE PATIENT AT THE TIME OF SPILL AND THE SURGEON REPORTED THAT HE WAS CONFIDENT THAT THE ENTIRE RESIDUE AMOUNT WAS RECOVERED DURING INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234327 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3310596

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR