BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC

    MDR report key: 5823036 · Received July 26, 2016

    Report

    Report Number
    1719045-2016-10571
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 19, 2016
    Report Date
    June 21, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 09-MAR-2006, PART#: 03.620.022, LOT#: 5130785 (NON-STERILE): STAR-DRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS CONFIRMED. THE DISTAL STARDRIVE TIP OF THE RETURNED SCREWDRIVER SHAFT IS SIGNIFICANTLY TWISTED (APPROXIMATELY 45 DEGREES) IN THE DIRECTION OF SCREW REMOVAL. THE STARDRIVE SCREWDRIVER SHAFT T25/SHORT (03.620.022) IS NOTED IN THREE TECHNIQUE GUIDES: PANGEA DEGENERATIVE SPINE, CANNULATED PANGEA AND PANGEA. THE DRIVER IS ONE OF SIX AVAILABLE IN THE SYSTEMS FOR FINAL TIGHTENING OF LOCKING CAP SETSCREWS (03.620.002/003/022/063/064/065). THE CHOSEN DRIVER SHAFT IS UTILIZED WITH A COUNTER TORQUE (03.622.018) AND 10NM TORQUE LIMITING RATCHET HANDLE (03.620.061). THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL DRIVER TIP WAS FOUND TO HAVE AN OBLIQUE FRACTURE RESULTING IN A FRAGMENT, APPROXIMATELY 8MM X 4MM, WHICH WAS RETURNED. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY APPLICATION OF EXCESSIVE TORSIONAL FORCE. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RECEIVED BY MANUFACTURER: INITIALLY REPORTED AS JULY 21, 2016; SHOULD HAVE BEEN JULY 11, 2016. 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

    PATIENT IDENTIFIER, DATE OF BIRTH/AGE, AND WEIGHT ARE UNKNOWN. DEVICE 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.

    Description of Event or Problem · 1

    DURING A SURGERY, THE SURGEON WAS USING A STARDRIVE SCREWDRIVER SHAFT TO REMOVE A POLYAXIAL SCREW. WHILE ATTEMPTING TO REMOVE THE SCREW THE HEAD OF THE SCREW POPPED OFF AND STRIPPED AND BENT THE SCREWDRIVER. THE SURGEON ATTEMPTED TO REMOVE THE SHAFT WITH ANOTHER DEVICE HOWEVER WAS UNSUCCESSFUL. THE SCREW SHAFT WAS LEFT IN PLACE. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474367 STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC SCREWDRIVER HXX SYNTHES MONUMENT 5130785

    Patients

    Seq Age Sex Outcome Treatment
    1