BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-HANDLE W/RATCHET-WRENCH+W/TORQ LIMIT 1

    MDR report key: 3183615 · Received June 22, 2013

    Report

    Report Number
    1719045-2013-01696
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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. 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 DEVICES WERE RETURNED FOR INSPECTION. WHILE, THE TIPS OF THE SCREWDRIVER SHAFTS DID BREAK DURING SURGERY THE INVESTIGATION OF BOTH THE T-HANDLE INSTRUMENTS THAT ARE USED TO HOLD THESE SCREWDRIVER SHAFTS DURING USE, HAVE SHOWN THAT BOTH DEVICES ARE IN PERFECT WORKING ORDER AND THE COMPLAINT CONDITION COULD NOT BE REPRODUCED. SEVERAL FUNCTIONAL TESTS HAVE SHOWN THAT THE MEASURED TORQUE WAS WITHIN THE GIVEN SPECIFICATIONS. FURTHER TESTS WITH THE T HANDLE SHOWED A PROPER LOCKING FUNCTIONALITY. IT IS NOTED THAT THE T HANDLE MECHANISM SHOULD ONLY BE RELEASED WHEN THE SCREWDRIVER PART IS POSITIONED AND SEATED ACCORDINGLY TO AVOID TIP BREAKAGE. 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. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND AS THE COMPLAINT CONDITION COULD NOT BE REPRODUCED THIS COMPLAINT IS CONSIDERED INVALID AND A NON-ISSUE. NO PRODUCT FAULT COULD BE DETECTED. IT IS NOTED THAT THE T HANDLE MECHANISM SHOULD ONLY BE RELEASED WHEN THE SCREWDRIVER PART IS POSITIONED AND SEATED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN LOCKING THE INNER SCREW WITH THE TORQUE LIMITING HANDLE AND THE SCREW DRIVER SHAFT THE TIP OF THE SCREWDRIVER BROKE. THIS WAS NOTICED BY THE SURGEONS AND THE DAMAGED PIECES WERE REMOVED. THE OPPOSITE SIDE HAD THE SCREWS INSERTED AND THE RODS AND CAPS HAD BEEN 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. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284329 T-HANDLE W/RATCHET-WRENCH+W/TORQ LIMIT 1 LXH SYNTHES MONUMENT 6577738-30

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention