BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3932951 · Received July 14, 2014

    Report

    Report Number
    2530088-2014-10184
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE RETURNED HELICAL BLADE COUPLING SCREW (LOT 4546584) WAS MANUFACTURED ON MAY, 2003 AND IS 11 YEARS OLD. THE HELICAL BLADE COUPLING SCREW WAS RECEIVED WITH THE KNURLED KNOB SEPARATED AT THE DISTAL END TUBE UNION. SEPARATED SURFACES ARE HOMOGENOUS WITH CLEAR MATERIAL SEPARATION, WELDMENT REMAINS INTACT. THE KNOB SHOWS EVIDENCE OF HEX DRIVE WEAR AND SUBSTANTIAL HAMMER MARKS ON THE PROXIMAL SIDE OF THE KNOB CONSISTENT WITH HEAVY USE. THE TUBE LENGTH SHOWS CONSIDERABLE DISCOLORATION, ROLL MARKS, AND SCRATCHES CONSISTENT WITH HEAVY USE. THE 2ND RETURNED PART IS A BLADE GUIDE SLEEVE (LOT 4305612) THAT WAS MANUFACTURED ON JUNE, 2002 AND IT 12 YEARS OLD. THE BLADE GUIDE SLEEVE WAS RECEIVED WITH MULTIPLE SCRATCHES, ROLL MARKS CONSISTENT WITH HEAVY USE. THE THREADS ON THE BLADE GUIDE SLEEVE WERE EXAMINED AND THEY ARE IN GOOD CONDITION THERE IS NO BENDING OR FOLDING OF THE THREADS. THE BLADE GUIDE SLEEVE WAS MATED WITH HELICAL BLADE INSERTER (PART 357.372, LOT 5753223) AND THERE WERE NO ERRORS OR ISSUES FOUND DURING THAT PROCESS. A REVIEW OF THE DESIGN DRAWING INDICATES THAT THE RETURNED BLADE GUIDE SLEEVE WAS MANUFACTURED TO AN OLDER DRAWING SINCE THEN THERE WERE TWO DESIGN CHANGES TO THE DRAWING THAT DID NOT AFFECT THE INTENDED USE OF THE DEVICE. THE COMPLAINT IS NOT CONFIRMED FOR THIS PART AND THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DESIGN DRAWING FOR THE HELICAL BLADE COUPLING SCREW (PART 357.377) INDICATES THAT THE RETURNED PART WAS MANUFACTURED TO AN OLDER DRAWING SINCE THEN THERE WERE FOUR DESIGN CHANGES TO THE DRAWING THAT DID NOT AFFECT THE INTENDED USE OF THE DEVICE. THE METHOD OF USE RATHER THAN A DESIGN DEFICIENCY HAS LED TO THIS COMPLAINT. THE CAUSE OF THIS COMPLAINT IS DUE TO THE SURGEON HAMMERING THE HEAD OFF-ANGLE OR THE SURGEON HAMMERING THE HEAD WHEN THE SCREW IS NOT FULLY TIGHTENED CAUSING THE KNURLED KNOB TO BREAK OFF. THEREFORE, THIS COMPLAINT IS CONFIRMED HOWEVER, THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COUPLING SCREW BROKE AT THE HEAD/SHAFT JUNCTION AFTER THE BLADE WAS SEATED. AFTER THE FINAL BLOW, THE HEAD SHEARED OFF AND HIT THE FLOOR. UPON REMOVAL ATTEMPTS, THE INSERTER MAY HAVE BEEN DAMAGED, AS WELL AS THE BLADE GUIDE SLEEVE. IT WAS REMOVED AFTER A LARGE FRAG DRIVER WAS JAMMED INTO THE CANNULA AND LEFT TURNED OUT. THE DRIVER FIT WELL ENOUGH TO ENGAGE THE CANNULA. THERE WAS A FIFTEEN MINUTE SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS FINE WITH NO ISSUES. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410712 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4546584

    Patients

    Seq Age Sex Outcome Treatment
    1