BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER FOR SIDE-OPENING IMPLANTS

    MDR report key: 3718366 · Received April 1, 2014

    Report

    Report Number
    9680938-2014-10008
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: A SCREWDRIVER FOR SIDE-OPENING IMPLANTS (03.602.001 LOT T932463) WAS RECEIVED WITH A BROKEN TAB ON THE DISTAL TIP. A DRAWING FOR THE SCREWDRIVER FOR SIDE-OPENING IMPLANTS WAS REVIEWED. THE DRAWING WAS FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE DISTAL TIP OF THE DRIVER WAS FOUND TO HAVE MET THE DIMENSIONAL DRAWING SPECIFICATIONS. ADDITIONALLY, THE MATERIAL (17-4PH SS) AND HEAT TREATING (H900) COMBINE FOR A HARDNESS RANGE OF HTC 40-47 WHICH IS COMMON FOR DEVICES OF SIMILAR APPLICATION. THE PRODUCT WAS RECEIVED UNDER THE COMPLAINT CONDITION BROKEN: INTRA-OPERATIVELY. ONE OF THE TABS ON THE DRIVER TIP WAS BROKEN OFF. THE COMPLAINT DESCRIPTION NOTES THAT THE TAB BROKE OFF WHEN TIGHTENING A SCREW INTO THE S2. THE INSTRUMENT IS NOTED TO BE AN OPTIONAL INSTRUMENT ON THE TECHNIQUE GUIDE FOR INSERTING UNIVERSAL SPINE SYSTEM SIDE-OPENING SCREWS. IN ORDER FOR THE TAB TO BREAK OFF, EXCESSIVE TORQUE MUST HAVE BEEN APPLIED TO THE INSTRUMENT. IT IS LIKELY THAT THE PEDICLE WAS NOT PROPERLY PREPARED, WHICH LED TO A CONDITION WHERE EXCESSIVE FORCE WAS REQUIRED TO INSERT THE SCREW. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS AND COMPLAINT HISTORY, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE DID FAIL, SO THE COMPLAINT IS CONFIRMED. SPECIFIC DETAILS REGARDING THE TECHNIQUE USED WHICH LED TO THE DEVICE FAILURE WAS NOT PROVIDED, HOWEVER IT IS LIKELY THAT EXCESSIVE FORCE WAS APPLIED TO THE DRIVER. IT IS POSSIBLE THAT THIS IS RESULTING FROM AN IMPROPERLY PREPARED PEDICLE. THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE UNIVERSAL SPINE SYSTEM, THE SCREWDRIVER BROKE DURING SURGERY. WHILE THE SURGEON WAS IMPLANTING A SACRAL SCREW INTO THE S2 POSITION, AND DUE TO THE SCREW BEING SUCH A LARGE SCREW, THE SIDE FLANGE OF THE SCREWDRIVER INSTRUMENT SNAPPED OFF AS THE SURGEON WAS TIGHTENING DOWN ON THE SCREW. THE SURGEON RETRIEVED THE BROKEN PIECE OF THE SCREWDRIVER. DUE TO THIS EVENT THERE IS A ADDITIONAL TEN MINUTE DELAY TIME IN SURGERY. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195707 SCREWDRIVER FOR SIDE-OPENING IMPLANTS SCREWDRIVERS HXX SYNTHES TUTTLINGEN T932463

    Patients

    Seq Age Sex Outcome Treatment
    1