BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR 2.9 AB SUTURE ANCHROR WITH 2 ULTRABRAID SUTURE

    MDR report key: 2801913 · Received October 23, 2012

    Report

    Report Number
    1219602-2012-00274
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    August 31, 2011
    Report Date
    September 12, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BROKEN PORTION OF AN ANCHOR WAS RETURNED FOR EVALUATION. DUE TO THE RETURNED CONDITION OF THE IMPLANT THE MANUFACTURE IS UNABLE TO PERFORM ANY FUNCTIONAL TESTING OR VISUALLY CONFIRM THAT THE RECEIVED IMPLANT IS IN FACT THE SAME PART NUMBER AS THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. IN ADDITION, A REVIEW OF THE STERILITY RECORDS WERE PERFORMED FOR THE REPORTED PART AND LOT NUMBERS WHICH CONFIRMED THAT THE LISTED LOT OF PRODUCT WAS STERILIZED PER STANDARD PROCESS. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THESE MANUFACTURED LOT NUMBERS ON FILE. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON INDICATES CULTIVATION RESULT OF THE TISSUES AS FOLLOWING: "IN PATIENT OVERALL TISSUE CULTURES GREW PROPIONIBACTERIUM ACNES, WHICH WAS SHOWN JUST BEFORE THE END OF THE YEAR. IT'S A TRICKY LITTLE VIRULENT THING. THEREFORE, I THINK THAT THE SUSPICION ON THE ANCHOR SIDE EFFECT FALLS". (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012, FROM REPORTER, THE CORRECT PART NUMBER IS 72200775, BIORAPTOR 2.9 AB SUTURE ANCHOR W/TWO 38" ULTRABRAID (#2) SUTURES. LOT NUMBERS ARE: 50339635 (2 EA) AND 50338375 (2 EA). RECEIVED ADDITIONAL INFO. ON (B)(4) 2012, INDICATED "REVISION WAS COMPLETED ON (B)(6) 2012. CULTIVATION OF THE TISSUES AND PLLA MATERIAL HAVE BEEN TAKEN AND WE WILL GET AN ANSWER WITHIN ONE MONTH. WE HAVE ALSO OBTAINED SMALL PIECES FROM THE RESORBABLE ANCHORS AND THE SUTURE MATERIAL AND A USB STICK WHICH INCLUDE THE SURGERY FROM (B)(6). THE SURGEON WILL BE ABLE TO SEND MRI PICTURES FROM 2010 AND 2012 ((B)(6)) WHEN THE ANONYMIZATION IS DONE AND ALSO THE JOURNAL ENTRIES." (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010 PATIENT RECEIVED A LEFT SHOULDER BANKART AND SLAP REPAIR USING A TOTAL OF FOUR BIORATOR 2.9 ANCHORS (WITH 1 ULTRABRAID). TWO YEARS POST-OPERATIVE THE PATIENT PRESENTED TO A SECOND PHYSICIAN COMPLAINING OF PAIN AT THE SURGICAL SITE. AN INVESTIGATION AND DIAGNOSTIC ARTHROSCOPY OF THE SURGICAL SITE WAS PERFORMED AND SYNOVIA WAS DISCOVERED. IT APPEARED THAT ONE OF THE ANCHORS HAD RELEASED FROM THE GLENOID EDGE AND AROUND THE ANCHOR PLACEMENT WHERE AN UNSPECIFIC OSTEOARTHRITIS HAD FORMED. THE PATIENT HAS SINCE BEEN TREATED WITH ANTIBIOTICS FOR THE INFECTIONS BUT STILL COMPLAINS OF PAIN. ADDITIONAL INFORMATION STATES THE PATIENT PRESENTED ON (B)(6) 2011 AT (B)(6) AT WHICH TIME A MRI WAS PERFORMED. THE PATIENT PRESENTED AGAIN ON (B)(6) 2012 AT (B)(6). THE STATUS OF THE PATIENT TO DATE WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND HAS MORE CREPITATION THAN EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR 2.9 AB SUTURE ANCHROR WITH 2 ULTRABRAID SUTURE BIORAPTOR 2.9 AB SUTURE ANCHROR WITH 2 ULTRABRAID SUTURE MAI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72200775 50339635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention