BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTRACTION LOCK REMOVAL BAR

    MDR report key: 3051845 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-10823
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    October 3, 2011
    Report Date
    October 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE DEVICE IS DESIGNED OF (B)(4) AND IS USED AS A WEDGE BETWEEN THE RIB SLEEVE AND DISTRACTION LOCK TO REMOVE DISTRACTION LOCK. THE DESIGN IS CORRECT FOR THE INTENDED USE. THE ALIGNMENT OF THE DEVICE TO THE MATING PARTS CANNOT BE DETERMINED. ALSO, WEAR ON PROXIMAL END MAY INDICATE DEVICE WAS STRUCK. THE FORCE WITH WHICH THE DEVICE WAS STRUCK ALSO CANNOT BE DETERMINED. THE MANUFACTURING EVALUATION SHOWED THAT A SMALL PIECE OF ONE PRONG IS BROKEN OFF AND THIS PRONG IS ALSO STRONGLY DEFORMED. THE OTHER PRONG IS SLIGHTLY DEFORMED. THE SURFACE AT THE END OF THE REMOVAL BAR IS ALSO STRONGLY DEFORMED AND HAS A HEAVY BURR ON BOTH FLAT SIDES. THE RELEVANT DIMENSIONS AT THE TIP OF THIS REMOVAL BAR CANNOT BE MEASURED ANYMORE BECAUSE OF THE DEFORMATIONS. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. THE DAMAGED END WITH THE HEAVY BURRS IS A CLEAR INDICATION FOR NUMEROUS HAMMER BLOWS OVER THE YEARS AND THAT THIS DEVICE WAS EXCESSIVELY USED. THEREFORE WE ASSUME THAT EXCESSIVE USE IN COMBINATION WITH WEAR AND TEAR CAUSED THE COMPLAINED MALFUNCTION. AS THE DIMENSIONS CANNOT BE VERIFIED THIS COMPLAINT IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VEPTR-EXPANSION PROCEDURE, THE TIP BROKE OFF THE DISTRACTION LOCK REMOVAL BAR (388.462), BUT WAS RETRIEVED BY SUCTION. THE SURGEON USED ANOTHER INSTRUMENT IN THE SET TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER PROBLEM.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148321 DISTRACTION LOCK REMOVAL BAR LXH SYNTHES GMBH 1191708

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR