BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPTORMITE 3.7 AB W/NDL,2#0 ULTRABRAID

    MDR report key: 15195998 · Received August 9, 2022

    Report

    Report Number
    1219602-2022-01126
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 13, 2022
    Report Date
    September 20, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010001887
    PMA / PMN Number
    K151105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE.¿ A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. WITH THE INFORMATION PROVIDED, THE REPORTED INABILITY OF THE DOCTOR TO SEE WHERE THE HOLE WAS, CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE REPORTED EVENTS. THE PATIENT IMPACT BEYOND THE ADDITIONAL BONE HOLE CANNOT BE DETERMINED WITH LIMITED INFORMATION PROVIDED. THEREFORE, NO FURTHER CLINICAL/ MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT.¿ NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DISTAL BICEP TEAR REPAIR, AFTER DRILLING TO PLACE THE RAPTORMITE ANCHOR, IT WAS DIFFICULT FOR SURGEON TO SEE WHERE THE HOLE WAS AS HE WAS ALSO RETRACTING TO SEE THE AREA WHERE THE ANCHOR WOULD BE PLACED. THEN, AFTER BEIN PLACED, THE ANCHOR CAME OUT OF THE BONE. AS A RESULT, A NEW BONE HOLE WAS DRILLED AND BACKUP ANCHOR WAS PLACED FOR THE REPAIR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398871 RAPTORMITE 3.7 AB W/NDL,2#0 ULTRABRAID SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 72201805 2068412 03596010001887

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other| R