BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    MDR report key: 3751174 · Received April 15, 2014

    Report

    Report Number
    9612488-2014-10096
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    MAX
    PMA / PMN Number
    PK072253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE PRODUCT DEVELOPMENT EVALUATION REPORTS, THE T15 U-JOINT DRIVER (PART # 03.802.431) IS PART OF THE SYNFIX-LR SYSTEM, WHICH IS A STAND-ALONE ANTERIOR INTERBODY FUSION DEVICE INDICATED FOR USE IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) (INFORMATION PROVIDED PER SYNFIX-LR SYSTEM TECHNIQUE GUIDE (B)(4). THE DEVICE WAS FREE-HAND TESTED TO SEE IF IT WOULD HOLD ANGULAR STABILITY (MEMORY). LOT # 8200534 TESTED ACCEPTABLE. THE PRIMARY PURPOSE OF THE U-JOINT MECHANISM ON THESE INSTRUMENTS IS TO ALLOW FOR THE TRANSMISSION OF TORQUE TO THE INSTRUMENT'S WORKING END (DRIVER) TO DIVERGENT ANGLES THE ACCESS EXPOSURE WOULD OTHERWISE NOT ACCOMMODATE FOR A STRAIGHT INSTRUMENT. ALTHOUGH THE DEVICE MAY LOSE STABILITY (MEMORY), THE DESIGN IS ADEQUATE FOR THE APPLICATION WITH THE USE OF THE GUIDING FORCEPS, AS SPECIFIED IN THE TECHNIQUE GUIDE. ADDITIONALLY, THE DESIGN WITH THIS TIP GEOMETRY AND MATERIAL HAS BEEN DEMONSTRATED THROUGH A USER HANDLING STUDY TO HAVE A MEAN LOCKING TORQUE OF 3.44 NM USING THE HANDLE SPECIFIED IN THE TECHNIQUE. THE MEAN ULTIMATE TORQUE OF THE TIP HAS BEEN DETERMINED THROUGH MECHANICAL TESTING TO BE 6.95 NM. THE TECHNIQUE GUIDE INSTRUCTS THAT THE SCREW IS LOCKED WHEN THE RING ON THE DRIVER MEETS THE ENTRY POINT ON THE AIMING DEVICE AND SHOULD NOT BE ADVANCED FURTHER. IT CONTAINS A WARNING THAT "EXCESSIVE TORQUE CAN DAMAGE OR BREAK THE INSTRUMENTS OR IMPLANT. USE FOUR FINGERS FOR FINAL TIGHTENING." A REVIEW OF THE MOST CURRENT REVISIONS OF THE DRAWINGS FOR PART 03.802.431 WAS PERFORMED AND THERE WERE NO CHANGES REQUIRED TO THE DESIGN OF THE T15 U-JOINT DRIVER. THE MATERIAL IS ALSO ADEQUATE FOR ITS INTENDED USE.PER THE TECHNIQUE GUIDE, THE TAPERED U-JOINT DRIVER (03.802.431) SHOULD BE USED WITH GUIDING FORCEPS (03.802.038) FOR POSITION GUIDANCE AND DIRECTIONAL CONTROL INTO AND OUT OF THE AIMING DEVICE DURING THE PROCEDURE. ADDITIONALLY, EXTREME BEARING LOADS ON THE PEEK BUSHINGS MIGHT REDUCE THE MEMORY CAPABILITY OF THE U-JOINT. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT UNKNOWN DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO NCRS WERE GENERATED DURING PRODUCTION. 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 DURING A ROUTINE INSPECTION OF FIELD EQUIPMENT POSTOPERATIVELY, SIX REPORTABLE INSTRUMENTS WERE DISCOVERED NOT TO BE FUNCTIONING PROPERLY. THREE LOCKING HOLDING SLEEVES AND ONE STANDARD HOLDING SLEEVE WERE ALL STRIPPED. ONE CURVED BALL TIP PROBE HAS TOO MANY BENDS ON IT TO USE PROPERLY. ONE TAPERED U-JOINT DRIVER HAS NO MEMORY. IT IS NOT KNOWN WHEN ALL OF THESE ITEMS STOPPED FUNCTIONING. THERE IS NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230035 TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN INTERVERTEBAL FUSION DEVICE, W/BONE GRAFT, LUMBAR MAX SYNTHES BETTLACH 8200534

    Patients

    Seq Age Sex Outcome Treatment
    1