BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    MDR report key: 3754081 · Received April 16, 2014

    Report

    Report Number
    2520274-2014-10794
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 27, 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

    NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: SIX TAPERED U-JOINT DRIVERS FOR SYNFIX (PART 03.802.431, LOT 2813613 MANUFACTURED JANUARY 2012, 7771071 MANUFACTURED MARCH 2012, 8626490 MANUFACTURED OCTOBER 2013 (X2), AND 8104858 MANUFACTURED OCTOBER 2012(X2)) WERE RETURNED WITH THE COMPLAINT OF ¿FLOPPY¿ AND HARD TO AIM. ALL SIX OF THESE DEVICES WERE TESTED AND FOUND TO HAVE LOST THEIR ANGULAR MEMORY; THE COMPLAINT FOR THESE DRIVERS WAS CONFIRMED. THE APPLICABLE AND ASSOCIATED DRAWINGS WERE REVIEWED. THESE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIALS (CUSTOM 465 STAINLESS STEEL AND PEEK), AND FINISHING PROCESSES FOR AN ANGLED T15 DRIVER WITH A U-JOINT WITH POSITION MEMORY. 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. THE U-JOINT HAS A MINIMUM OF .026MM DIAMETRICAL INTERFERENCE BETWEEN THE PIN AND PEEK BUSHING TO CREATE THIS POSITION MEMORY. THE PEEK BUSHING PROVIDED POSITIONAL RETENTION, EXCESSIVE TORSIONAL FORCE MAY PERMANENTLY DEFORM IT AFFECTING THE RETENTION FEATURE HOWEVER THE DESIGN IS ADEQUATE FOR THE APPLICATION WITH THE USE OF THE GUIDING FORCEPS, AS SPECIFIED IN THE TECHNIQUE GUIDE. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS COMPLAINT IS CONFIRMED. THE ANGULAR STABILITY (MEMORY) HAS BEEN LOST TO SOME DEGREE AT THE U-JOINT. THIS OBSERVATION IS CONSISTENT WITH AN EXTREME BEARING LOAD APPLIED WHICH MAY REDUCE THE MEMORY CAPABILITY OF THE U-JOINT. EXTREME TORQUE MAY CAUSE DEFORMATIONS TO THE PEEK BUSHINGS HOWEVER THE DESIGN ALLOWS INTERFERENCE TO CREATE U-JOINT POSITION MEMORY AND IT IS FOUND ADEQUATE FOR THE APPLICATION WITH THE USE OF THE GUIDING FORCEPS, AS SPECIFIED IN THE TECHNIQUE GUIDE. 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 AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE SYNFIX MINI-OPEN HAD LOST THEIR ABILITY TO HOLD DESIRED ANGLES, RENDERING THEM "FLOPPY".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELEVEN DEVICES WERE DAMAGED DUE TO NORMAL WEAR AND TEAR. EIGHT TAPERED U-JOINT DRIVERS FOR SYNFIX MINI-OPEN (03.802.431) ARE "FLOPPY", SAGGY, AND HARD TO AIM. TWO HOLDING SLEEVES-STANDARD FOR MATRIX HAVE STRIPPED OUT THREADING. ONE STRAIGHT TIP T25 DRIVER-LONG IS STRIPPED. THE EVENTS ARE NOT RELATED TO ANY SPECIFIC CASE OR PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. THIS IS REPORT 7 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233303 TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR MAX SYNTHES BETTLACH 2813613

    Patients

    Seq Age Sex Outcome Treatment
    1