BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 3002531 · Received March 13, 2013

    Report

    Report Number
    8030965-2013-10461
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    January 4, 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

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. MANUFACTURING EVALUATION MANUFACTURING VISUAL EXAMINATION NOTED THE CARDAN JOINT IS BENT/DAMAGED. THE FOR THIS EVENT REFERRING DIMENSIONS ARE NOT MEASURABLE TO ORIGINAL SPECIFICATIONS BECAUSE OF THE DAMAGE. THE INVESTIGATION DETERMINED THAT THE DAMAGE WAS CAUSED POST-MANUFACTURING, APPARENTLY BY APPLYING TOO MUCH FORCE DURING A PROCEDURE. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PRODUCT DEVELOPMENT EVALUATION: THE ANGLE DRIVER WAS RECEIVED IN THE ASSEMBLED CONDITION. THE DRIVER TIP DID WOBBLE WHEN TURNED AS DESCRIBED IN THE COMPLAINT DESCRIPTION; HOWEVER IT WAS POSSIBLE TO ADVANCE A SCREW WITH THE DRIVER. IT WAS DIFFICULT TO DISASSEMBLE THE DRIVER SHAFT FROM THE SLEEVE BECAUSE THE TIP OF THE DRIVER SHAFT WAS DAMAGED. THE DRIVER WAS DISASSEMBLED BY TURNING THE SHAFT IN THE SLEEVE TO A POSITION WHERE THE DISASSEMBLY RESISTANCE WAS SLIGHTLY LESS. THE COUNTER-TORQUE HANDLE FUNCTIONED CORRECTLY AND COULD BE EASILY DISASSEMBLED. THE CARDON JOINT WAS INTACT, BUT THE YOKE WAS SLIGHTLY SPLAYED OPEN ON THE DRIVER SHAFT SIDE, WHICH IS WHAT CAUSED THE DIFFICULT DISASSEMBLY OF THE DRIVER FROM THE SLEEVE. THERE WAS EVIDENCE OF WEAR ON THE CARDON JOINT, WHICH INDICATES INTERFERENCE/RUBBING AGAINST THE SLEEVE. THE DRIVER TIP WAS SLIGHTLY WORN BUT STILL CAPABLE OF TURNING A SCREW. THE INSIDE OF THE SLEEVE HAD SMALL GOUGES NEAR THE LOCATION OF THE CARDON JOINT, BUT THE REST OF THE DRIVER AND SLEEVE WERE UNDAMAGED. THE TIP OF THE DRIVER ASSEMBLY IS TESTED TO WITHSTAND A MAXIMUM TORQUE OF (B)(4), WHICH IS GREATER THAN THE TORQUE REQUIRED TO LOCK THE SCREW TO THE PLATE. THE SLEEVE IS DESIGNED TO HOUSE THE CARDON JOINT, HOWEVER ANY SPLAY IN THE JOINT COULD CAUSE RESISTANCE WITH THE SLEEVE. THE EVIDENCE INDICATES THAT THE POSSIBLE ROOT CAUSE COULD HAVE BEEN DUE TO EXCESSIVE TORQUE, WHICH WOULD HAVE DAMAGED THE CARDON JOINT. THE DEFORMATION OF THE YOKE CAUSED THE TIP TO WOBBLE AND DIFFICULT DISASSEMBLY OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER THE TIP OF THE ANGLED SCREWDRIVER FOR ZERO-P (03.617.900) IS WOBBLING AND CANNOT BE TIGHTENED, USED OR DISASSEMBLED. ALL OF THE SYNFIX SCREWDRIVERS WILL NOT ENGAGE AND HOLD SCREW. THE LAMINA ELEVATOR (388.170) WILL NOT LOCK INTO POSITION EITHER OPEN OR CLOSED. THIS IS FOR THE ANGLED SCREWDRIVER AND THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105693 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING OVE SYNTHES GMBH 3232866

    Patients

    Seq Age Sex Outcome Treatment
    1