BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3193601 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03658
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE PRESENT SCREWDRIVER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOTS IN QUESTION. THE BROKEN SURFACES ARE HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS IT IS CONCLUDED THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. IT IS CLEARLY VISIBLE THAT BOTH TIPS WERE TWISTED BEFORE THE BREAKAGE. THESE FINDINGS ARE INDICATIONS THAT TOO MUCH TORQUE WAS APPLIED ONTO THIS INSTRUMENT WHILE THE SCREW WAS TIGHTENED.

    Description of Event or Problem · 1

    TIP OF SCREWDRIVER BROKE AWAY. L3/L4 POSTER LATERAL FUSION. TWO SCREWS IN ONE SIDE INSERTED, THEN RODS AND LOCKING CAP PLACED. WHEN LOCKING THE INNER SCREW WITH THE TORQUE LIMITING HANDLE AND THE ABOVE SCREWDRIVER SHAFT THE TIP OF THE SCREWDRIVER BROKE AWAY. THIS WAS NOTICED BY THE SURGEONS AND THE DAMAGED PIECES WERE REMOVED. THE OPPOSITE SIDE HAD THE SCREWS INSERTED AND THE RODS AND CAPS PLACED. THE SCRUB NURSE THEN NOTICED THAT THE SECOND SCREWDRIVER SHAFT WAS ALSO MISSING THE TIP OF THE SHAFT. THE CAPS AND RODS WERE REMOVED AND THE MISSING TIP WAS DISCOVERED SITTING IN THE RECESS OF THE URS PEDICLE SCREW. BOTH SHAFTS WERE NOW UNUSABLE AND 3 LOCKING CAPS STILL NEEDED TO BE LOCKED DOWN. AN EXPERT TIBIAL NAIL SET WAS OPENED AND THE T25 STAR DRIVE SCREWDRIVER FROM THIS SET WAS USED TO COMPLETE THE PROCEDURE. THIS ADDED APPROXIMATELY 30 MINUTES TO THE ANESTHETIC TIME. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294106 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3707449

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention