BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL

    MDR report key: 14809396 · Received June 24, 2022

    Report

    Report Number
    3007593722-2022-00002
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    June 9, 2022
    Report Date
    August 1, 2022
    Manufacturer
    MEDSHAPE, INC
    Product Code
    JDS
    PMA / PMN Number
    K113828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDSHAPE WAS NOTIFIED THAT DURING THE POST OPERATIVE OBSERVATION THAT A DYNANAIL AND THE MOST PROXIMAL SCREW BROKE AT THE MOST NEAR THE TALUS, PAIN TO THE PATIENT WAS NOT REPORTED AT THIS TIME. THE BROKEN NAIL AND HEADLESS SCREW ARE EXPECTED TO BE RETURNED TO MEDSHAPE FOR INVESTIGATION. THE PATIENT INFORMATION, ORIGINAL IMPLANT DATE AND LOT INFORMATION ARE UNKNOWN AT THIS TIME ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    MEDSHAPE WAS NOTIFIED THAT DURING THE POST OPERATIVE OBSERVATION THAT A DYNANAIL MINI AND THE MOST PROXIMAL SCREW BROKE AT THE MOST PROXIMAL END NEAR THE TALUS, AND IT WAS INITIALLY UNKNOWN IF THE PATIENT HAD PAIN. ADDITIONAL DISCUSSION ON 28JUL2022 CONFIRMED THAT THE PATIENT REPORTED PAIN AND SWELLING SEVERAL DAYS PRIOR TO THE REMOVAL CASE ON (B)(6) 2022, THUS CONFIRMING THE NECESSITY FOR THIS MDR. WHILE IT WAS INITIALLY REPORTED THAT THE EXPLANTED DEVICE WOULD BE RETURNED, FURTHER FOLLOW UP CONFIRMED THAT THE EXPLANTED DEVICE WAS DISCARDED AND THUS WAS NO LONGER AVAILABLE FOR EVALUATION IN COMPLAINT INVESTIGATION (B)(4). FURTHER DISCUSSION WAS HELD WITH THE SURGEON WHO REMOVED THE DEVICE AND THE SURGEON WHO ORIGINALLY IMPLANTED THE DEVICE. THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE ROOT CAUSE OF THE BROKEN DYNANAIL MINI AND OTHER NON-MEDSHAPE HARDWARE CAN BE ATTRIBUTED TO PATIENT NON-COMPLIANCE IN THE FIRST ALLOWED WEIGHT-BEARING PHASE POST-OPERATIVELY, AS CONFIRMED BY THE SURGEON WHO ORIGINALLY IMPLANTED THE DEVICE, AND SUBSEQUENT ADDITIONAL INCIDENT(S) THAT APPEARED TO CAUSE FURTHER HARDWARE DAMAGE AND SHIFTING. A CONTRIBUTING FACTOR IS THAT THE PATIENT WAS OVERWEIGHT AND FOLLOWING THE INITIAL OBSERVATION OF MINOR NAIL BODY BREAKAGE, THE SURGEON OPTED TO LEAVE THE IMPLANT IN THE PATIENT. DUE TO LACK OF LOT NUMBER / PART NUMBER TRACEABILITY, LACK OF ORIGINAL SAMPLE, IN CONJUNCTION WITH NO REPORTED ISSUES DURING THE INITIAL IMPLANTATION OF THE DEVICE, THERE IS NO INDICATION OF THAT THIS NAIL BREAKAGE WAS THE RESULT OF A MANUFACTURING NON-CONFORMANCE OR SURGICAL TECHNIQUE ISSUE. THUS, NO ACTION WILL BE NECESSARY FOR ANY DYNANAIL MINI UNITS CURRENTLY IN THE FIELD, AS THIS EVENT HAS A ROOT CAUSE RELATED TO PATIENT NON-COMPLIANCE. DUE TO AN OVERALL LOW COMPLAINT RATE OF (B)(4) (2 DEVICES WITH REPORTED COMPLAINT / 235 DYNANAIL MINI'S RELEASED LAST 12 MONTHS) FOR THIS FOR THIS FAILURE MODE ON DYNANAIL MINI AND KNOWN ROOT CAUSE BEING TO UNRELATED TO ANY PART OF THE MANUFACTURING OR SURGICAL PROCESS, NO CORRECTIVE / PREVENTIVE ACTION IS NECESSARY AT THIS TIME. NO ADDITIONAL PATIENT PAIN / HARM HAS BEEN REPORTED BY THE PATIENT FOLLOWING REMOVAL AND REVISION SURGERY ON (B)(6) 2022. FUTURE COMPLAINTS OF THIS NATURE WILL BE MONITORED AND ASSESSED FOR ANY FUTURE NECESSARY ACTIONS. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    MEDSHAPE WAS NOTIFIED THAT DURING THE POST OPERATIVE OBSERVATION THAT A DYNANAIL AND THE MOST PROXIMAL SCREW BROKE AT THE MOST NEAR THE TALUS, PAIN TO THE PATIENT WAS NOT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608934 DYNANAIL DYNANAIL TTC FUSION NAIL JDS MEDSHAPE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other DYNANAIL HEADLESS SCREW