BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI 12-POINT NUT-11MM

    MDR report key: 3021648 · Received March 26, 2013

    Report

    Report Number
    2530088-2013-00361
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW FOUND NO RELEVANT ISSUES THAT WOULD RESULT IN THIS PRODUCT COMPLAINT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRODUCT WENT TO AN ENGINEER TO BE EVALUATED: THE 388.612 IS CLEARLY BENT AT THE INTERNAL THREADED SHAFT. ATTEMPTING TO APPLY A NUT TO THE CONSTRUCT OVER THIS SHAFT COULD POSSIBLY LEAD TO CROSS-THREADING OF THE NUT ON THE SCREW AS THE AXIS IS NO LONGER ALIGNED. IT IS NOT CLEAR HOW OR WHEN THE SHAFT WAS BENT, BUT GIVEN THE MIS-ALIGNMENT, CROSS-THREADING COULD OCCUR WHICH WOULD BE CONDUCIVE TO THE DIFFICULTY EXPERIENCED BY THE SURGEON WHEN ATTEMPTING TO PLACE THE NUT. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE DEVICES INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE ANODIZE FINISH HAS BEEN REMOVED FROM THE FIRST TWO THREADS, FROM THE D3 DIAMETER AND DAMAGE ON THE EDGES OF THE OUTSIDE SHAPE OF THE NUT. ALL RELEVANT FEATURES CONFORM TO PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING L2-L4 POSTERIOR FUSION WITH USS DUAL OPENING. WHEN CONNECTING THE RODS, HE COULD NOT GET THE NUT TO ENGAGE ON THE RIGHT L4 7.0 X 50MM DO SCREW. THE SURGEON ATTEMPTED TO ENGAGE FIVE USS DONUTS BUT THE THREADS HAD STRIPPED AT THE TOP OF THE SCREW. THE SURGEON REPLACED THE 7.0 X 50MM SCREW WITH A 8.0 X 50MM DO SCREW AND ATTEMPTED 2 MORE SETS OF NUTS AND COLLARS BUT THE NUTS WOULD STILL NOT ENGAGE THE THREADS ON THE SCREW. THE SURGEON STRIPPED THE THREADS ON THE 8.0 X 50MM SCREW AND REPLACED IT WITH ANOTHER 8.0 X 50MM SCREW AFTER THE BENDING OF THE ROD IN SITU. WHEN THE SURGEON REMOVED THE SCREW IT WAS NOTICED THAT THE GUIDE STICK WAS BENT, AND STILL REMAINS ON THE SCREW. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH NO HARM TO PATIENT. THIS IS 5 OF 12 REPORTS FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS 5 OF 12 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123823 TI 12-POINT NUT-11MM NKB SYNTHES BRANDYWINE 7126695

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention