BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE STAPLE

    MDR report key: 7069146 · Received November 29, 2017

    Report

    Report Number
    2939274-2017-50069
    Event Type
    Injury
    Date Received
    November 29, 2017
    Report Date
    November 1, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN BME STAPLE. PART AND LOT NUMBERS ARE UNKNOWN. THE UDI NUMBER IS NOT AVAILABLE. 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 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

    SCHIPPER, O; ET AL (2017) RADIOGRAPHIC RESULTS OF NITINOL COMPRESSION STAPLES FOR HINDFOOT AND MIDFOOT ARTHRODESES. FOOT & ANKLE INTERNATIONAL, 1-8. THIS REPORT IS FOR AN UNKNOWN BME SPEEDTITAN STAPLE. PART AND LOT NUMBERS ARE UNKNOWN. THE UDI NUMBER IS NOT AVAILABLE. (510K): UNKNOWN. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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. (B)(4).

    Description of Event or Problem · 1

    FURTHER IT WAS CLARIFIED THAT THIS REPORT IS FOR BME STAPLE (NOT FOR BME SPEEDTITAN STAPLE AS REPORTED ON INITIAL MEDWATCH) AND IS FOR 1 UNKNOWN FEMALE PATIENT WHO EXPERIENCED REVISION ARTHRODESIS, PARTIAL UNION OF THE TALONAVICULAR JOINT, SIGNIFICANT PAIN AND REVISION SURGERY. IT WAS UNKNOWN WHICH DEVICE WAS USED.

    Description of Event or Problem · 1

    FURTHER IT WAS CLARIFIED THAT 8 PATIENTS EXPERIENCED BME IMPLANT BREAKAGE AND NOT 5 AS ORIGINALLY REPORTED AND TOTAL OF 11 BME IMPLANTS BROKE IN THESE 8 PATIENTS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: SCHIPPER, O; ET AL (2017) RADIOGRAPHIC RESULTS OF NITINOL COMPRESSION STAPLES FOR HINDFOOT AND MIDFOOT ARTHRODESES. FOOT & ANKLE INTERNATIONAL, 1-8. THIS A RETROSPECTIVE STUDY FROM JANUARY 1, 2012, AND DECEMBER 31, 2016 TO DETERMINE THE RADIOGRAPHIC UNION RATE AFTER MIDFOOT AND HINDFOOT ARTHRODESES USING A NEW GENERATION OF NITINOL STAPLES, AND TO COMPARE OUTCOMES BETWEEN A NITINOL STAPLE CONSTRUCT AND A NITINOL STAPLE AND PARTIALLY THREADED COMPRESSION SCREW CONSTRUCT. A TOTAL OF 96 PATIENTS AND 149 JOINTS MET INCLUSION CRITERIA. A SINGLE FELLOWSHIP-TRAINED FOOT AND ANKLE SURGEON PERFORMED ALL PROCEDURES. A NEW-GENERATION BME ELITE STAPLE WAS USED FOR ALL CASES, WITH OR WITHOUT A PARTIALLY THREADED SCREW. IN CASES WHERE THERE WAS INADEQUATE SPACE FOR A BME ELITE STAPLE, A THINNER BRIDGE BME SPEEDTITAN STAPLE WAS USED INSTEAD; BIOMEDICAL ENTERPRISES ELITE, SPEEDTITAN; DEPUY SYNTHES, LEEDS, UNITED KINGDOM. IN THE NITINOL STAPLE GROUP, (60/64) OF PATIENTS HAD RADIOGRAPHIC EVIDENCE OF UNION. OF THE 4 WITH NONUNION, 2 WERE ASYMPTOMATIC AND DID NOT REQUEST REVISION SURGERY AND THE OTHER 2 PATIENTS, ONE OF WHOM WAS A DIABETIC AND UNDERWENT REVISION ARTHRODESIS. (2/64) PATIENTS UNDERWENT REMOVAL OF STAPLES FOR HARDWARE IRRITATION. OF THE 4 PATIENTS WITH NONUNION, 3 HAD EVIDENCE OF A BROKEN STAPLE AND NONE REQUIRED SURGERY FOR REMOVAL. IN THE STAPLE AND SCREW GROUP (29/32) PATIENTS HAD RADIOGRAPHIC EVIDENCE OF UNION. OF THE 3 PATIENTS WITH NONUNION, 1 PATIENT UNDERWENT REVISION ARTHRODESIS AND HAD EVIDENCE OF A PARTIAL UNION OF THE TALONAVICULAR JOINT BASED ON CT IMAGING, BUT HAD CONTINUED SIGNIFICANT PAIN, REQUIRING REVISION SURGERY. ONE NONUNION HAD NOT YET UNDERGONE REVISION SURGERY, BUT SHE WAS SYMPTOMATIC AND IN THE PROCESS OF BEING CONTACTED FOR POSSIBLE REVISION ARTHRODESIS AT THE TIME OF THIS STUDY. THE THIRD NONUNION PATIENT WAS ASYMPTOMATIC. OF THESE 3 PATIENTS, 2 HAD EVIDENCE OF A BROKEN STAPLE AND NONE REQUIRED SURGERY FOR REMOVAL. THIS REPORT IS FOR AN UNKNOWN BME SPEEDTITAN STAPLE. THIS BME SPEEDTITAN REPORT IS FOR 1 UNKNOWN FEMALE PATIENT WHO EXPERIENCED REVISION ARTHRODESIS, PARTIAL UNION OF THE TALONAVICULAR JOINT, SIGNIFICANT PAIN AND REVISION SURGERY. IT WAS UNKNOWN WHICH DEVICE WAS USED. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847611 BONE STAPLE JDR WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention