BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 3062851 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10815
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. REMEDIATION PARAGRAPH MISSING ON INITIAL REPORT. -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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION NOTED THAT THE TIP WAS BROKEN OFF AND WAS NOT SEND BACK FOR EVALUATION. THE SHAFT IS HARD TO DISASSEMBLE FROM THE OUTER SLEEVE AS THE CARDON JOINT IS SPLAYED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THIS FINDING AND THE SPLAYED CARDON JOINT ARE AN INDICATION THAT TOO MUCH TORQUE WAS APPLIED ONTO THIS SCREWDRIVER, WHICH CAN CAUSE SUCH A BREAKAGE. PRODUCT DEVELOPMENT EVALUATION STATED THAT THE ANGLED SCREW DRIVER WAS RECEIVED IN THE ASSEMBLED CONDITION. THE TIP OF THE DRIVER WAS BROKEN OFF NEAR THE WELD JOINT; THE TIP WAS NOT RETURNED. IT WAS DIFFICULT TO DISASSEMBLE THE DRIVER SHAFT FROM THE SLEEVE BECAUSE THE CARDON JOINT WAS DAMAGED. THE DRIVER WAS DISASSEMBLED BY TURNING THE SHAFT IN THE SLEEVE TO A POSITION WHERE THE DISASSEMBLY RESISTANCE WAS SLIGHTLY LESS. THE CARDON JOINT WAS INTACT, BUT THE YOKE WAS SLIGHTLY SPLAYED OPEN ON THE DRIVER SHAFT SIDE. THERE WAS EVIDENCE OF WEAR ON THE CARDON JOINT, WHICH INDICATES INTERFERENCE/RUBBING AGAINST THE SLEEVE. THE COUNTER-TORQUE HANDLE FUNCTIONED CORRECTLY AND COULD BE EASILY DISASSEMBLED. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE. THE EVIDENCE INDICATES THAT THE POSSIBLE ROOT CAUSE COULD HAVE BEEN DUE TO EXCESSIVE TORQUE, WHICH COULD HAVE BROKEN THE DRIVER TIP AT WELD AND CAUSED THE CARDON JOINT TO SPLAY OPEN SLIGHTLY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ANTERIOR CERVICAL DECOMPRESSION FUSION (ACDF) PROCEDURE, THE SURGEON WAS INSERTING THE SCREW AND THE TIP OF THE SCREWDRIVER (03.617.900) BROKEN OFF. THE BROKEN FRAGMENT WAS RETRIEVED AND DISCARDED OF BY THE FACILITY. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164370 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING OVE SYNTHES GMBH 7583139

    Patients

    Seq Age Sex Outcome Treatment
    1