BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS CROSS CONNECTOR 20MM

    MDR report key: 2961991 · Received February 14, 2013

    Report

    Report Number
    0009617544-2013-00029
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K070631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE RETURNED FIXED CROSS CONNECTOR WAS CONFIRMED TO BE BROKEN AT RECEIPT. BREAKAGE OCCURRED AT ONE SIDE OF CLAMP SUPPORTING THAT THE LEVERAGE EFFORT WAS NOT PROVIDED ON THE CONNECTOR BODY BUT AT THIS LEVEL. THIS IS ALSO HIGHLIGHTED BY THE SHARD THE BREAKAGE HAS GENERATED AT THIS LEVEL. MARKS OF RUBBING LIKELY DUE TO THE INSTRUMENTATION USED TO PERFORM THE BENDING ALSO SUGGEST IMPROPER GRIP OR POSITIONING OF THE BENDING INSTRUMENT. FUNCTIONAL INSPECTION: NOT APPLICABLE. DEVICE HISTORY REVIEW: REVIEW OF THE MANUFACTURING RECORDS OF BATCH 11C702 WAS PERFORMED. NO DEVIATION IN REGARDS WITH THE FAILURE MODE REPORTED WAS HIGHLIGHTED. (B)(4). COMPLAINT HISTORY: THE COMPLAINT DATABASE WAS SEARCHED TO DETECT POTENTIAL SIMILAR EVENTS ON THIS PRODUCT BRAND. THE SEARCH WAS DONE SINCE THE LAUNCH OF THE COMPLAINT DATABASE IN MARCH 2004 UNTIL DECEMBER 31, 2012 FOR ALL RADIUS PRIMARY PRODUCTS. A FILTER WAS THEN APPLIED ON IMPLANT AND THEN ON DEVICES THAT CONTAINS CONNECTOR IN MANUFACTURING DESCRIPTION. OUT OF THE 7 COMPLAINTS MATCHING WITH THIS SEARCH, NONE OF THEM WERE ASSOCIATED TO THE PRESENT FAILURE MODE MAKING THIS ISSUE ISOLATED. CONCLUSION: BASED ON THE OBSERVATIONS OF THE RETURNED PARTS IT IS LIKELY THAT THE BENDING MOMENT WAS NOT APPROPRIATELY APPLIED PUTTING CONSTRAINTS IN THE THINNEST SECTION OF THE DEVICE LEADING TO BREAKAGE. THE FACT EVENT REPORTS SURGEON COULD NOT FIT THE DEVICE IN THE CROSS CONNECTOR BENDER AND PROCEED FORCIBLY TO BEND THE DEVICE SUPPORTS ALSO SUPPORTS THIS STATEMENT. BENDING OF CONNECTOR IS PERFORMED OUT OF PATIENT WOUND: HENCE THE EVENT AS REPORTED WOULD NOT HAVE INVOLVED ADVERSE CONSEQUENCES FOR PATIENT. BASED ON THE REPORTED INFORMATION SURGICAL TECHNIQUE ON PAGE 19 EXPLAINS HOW TO PROCEED TO BEND FIXED CROSS CONNECTORS: PLACE EITHER FIXED CROSS CONNECTOR CLAMP INTO THE FIXED CROSS CONNECTOR SLOT OF THE CROSS CONNECTOR BENDER. PLACE THE OTHER CLAMP OF THE FIXED CROSS CONNECTOR INTO THE FIXED NEST SLOT BUILT INTO THE TOP OF THE CROSS CONNECTOR J-TIP BENDER. A WARNING IS ALSO PROVIDED IN CASE OF OVER BENDING THAT MAY RESULT IN BREAKAGE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION, COMPLAINT HISTORY ANALYSIS, DHR REVIEW, LABELLING REVIEW, RISK ASSESSMENT RESULT: AFTER VISUAL INSPECTION THE BREAKAGE OF THE RETURNED IMPLANT WAS CONFIRMED. BENDING WAS APPLIED IN THE THINNEST SECTION OF THE DEVICE WHICH LED TO BREAKAGE. REVIEW OF COMPLAINT HISTORY: THIS IS THE FIRST COMPLAINT REPORTED OF THIS NATURE. DHR REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOUND NO DEVIATIONS OR ANOMALIES THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. LABELLING REVIEW: THE SURGICAL TECHNIQUE CLEARLY STATES THE STEPS TO BEND FIXED CROSS CONNECTORS. A WARNING IS ALSO PROVIDED IN CASE OF OVER BENDING THAT MAY RESULT IN BREAKAGE. RISK ASSESSMENT: BENDING OF CONNECTOR IS PERFORMED OUT OF PATIENT WOUND SO IF IT RECUR DURING SURGERY WOULD NOT HAVE INVOLVED ADVERSE CONSEQUENCES FOR PATIENT THERE WAS NO ADVERSE CONSEQUENCE REPORTED TO THE PATIENT AS A RESULT OF THIS EVENT. CONCLUSION: THE BREAKAGE IS BELIEVED TO BE THE RESULT OF THE USER ERROR. THE SURGICAL TECHNIQUE WAS NOT WELL FOLLOWED. THIS IS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    AS REPORTED "DURING RADIUS SURGERY, THE 20MM CROSS CONNECTOR ((B)(4)) COULD NOT FIT IN THE CROSS CONNECTOR BENDER. BECAUSE THE SURGEON WAS GOING TO BEND IT FORCIBLY, IT BROKE. HE USED 22MM CROSS CONNECTOR ((B)(4)) INSTEAD."

    Description of Event or Problem · 1

    AS REPORTED "DURING RADIUS SURGERY, THE 20MM CROSS CONNECTOR (486614220) COULD NOT FIT IN THE CROSS CONNECTOR BENDER. BECAUSE THE SURGEON WAS GOING TO BEND IT FORCIBLY, IT BROKE. HE USED 22MM CROSS CONNECTOR (486614222) INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65647 RADIUS CROSS CONNECTOR 20MM IMPLANT MNH STRYKER SPINE-FRANCE 11C702

    Patients

    Seq Age Sex Outcome Treatment
    1