BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL

    MDR report key: 24958574 · Received April 22, 2026

    Report

    Report Number
    3007593722-2026-00002
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HSB
    UDI-DI
    M97012000110220
    PMA / PMN Number
    K171376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AGENT REPORTED FAILURE OF IMPLANT. THIS COMPLAINT WAS OPENED ON ACCOUNT OF A REVISION SURGERY DUE TO A NON-FUSION OF A DYNANAIL TTC IMPLANT. THE SAMPLE WAS NOT RETURNED AS THE EXPLANTED ITEMS WERE DISCARDED AT THE FACILITY, ADDITIONALLY NO VISUALS WERE PROVIDED, THUS A COMPLETE EVALUATION AND INVESTIGATION COULD NOT BE CONDUCTED. THE REPORTED STATED THAT THE INDICATION OF A NECESSARY REVISION SURGERY WAS PATIENT PAIN. THE REPORT NOTED THAT THE PATIENT HAD A MAJOR DEFORMITY WHICH MADE IT WAS DIFFICULT TO GET ALIGNMENT DURING THE CASE. THE SURGEONS HAD TO TAKE OUT THE MEDIAL MAL TO GET THE ALIGNMENT NEEDED FOR FUSION. THIS IS A POTENTIAL ROOT CAUSE FOR THE FAILED FUSION; HOWEVER, NO DEFINITIVE ROOT CAUSE OF THE FAILURE COULD BE CONFIRMED. THE POTENTIAL HAZARD IS IDENTIFIED IN RISK-FA001-0002 FMEAS DYNANAIL TTC REV A. IN THE UFMEA, IT IS RECORDED AS PATIENT EXPERIENCES MALUNION WITH AN EFFECT OF MINOR INJURY TO PATIENT. THIS POTENTIAL HAZARD IS RANKED WITH SEVERITY OF 2 AND OCCURRENCE OF 4. THE POTENTIAL CAUSE OF THE FAILURE INCLUDES USE ERROR, PATIENT ANATOMY, AND FAILURE TO FOLLOW IFU. ACCORDING TO THE REFERENCED IFU STATEMENT IN THE UFMEA, THE DYNANAIL TTC FUSION NAIL IS INTENDED TO FACILITATE HEALING BUT IS NOT DESIGNED TO SUPPORT THE PATIENT'S BODY WEIGHT IN THE PRESENCE OF A DELAYED UNION OR NONUNION OF BONE. A POTENTIAL ADVERSE EFFECT OF THIS HAZARD IS LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS AND/ OR MARKEDLY UNSTABLE COMMINUTED FRACTURES. IT IS UNKNOWN IF THE SURGICAL TECHNIQUE WAS ADHERED TO WITH THE INFORMATION PROVIDED, BUT THERE WERE NO REPORTED DEVIATIONS. A HISTORICAL SEARCH WAS CONDUCTED FROM THE TIMEFRAME OF (B)(6) 2025 TO (B)(6) 2026 AND SHOWED THAT THIS IS THE SECOND REPORTED INCIDENT OF A NON-FUSION REVISION SURGERY WITHIN THE DYNANAIL TTC PRODUCT FAMILY AND WITHOUT A DEFINITIVE PROBABLE CAUSE OR CONCLUSION. THE OCCURRENCE LEVEL PERCENTAGE WAS DETERMINED FROM THE DOCUMENT 3000.1635 RISK MANAGEMENT WHERE AN OCCURRENCE LEVEL OF 4 HAS A THRESHOLD OF GREATER THAN 0.1% AND LESS THAN OR EQUAL TO 1%. SALES VOLUME OF THE PART IN THIS SAME TIMEFRAME WERE AT 2656 UNITS. THE OCCURRENCE RATE OF THIS FAILURE MODE FOR THE YEAR IS .075%. THE OCCURRENCE IS WITHIN THE ANTICIPATED THRESHOLD. THERE IS NO FURTHER ACTION NEEDED. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND THE CURRENT OCCURRENCES ARE WITHIN THE ANTICIPATED THRESHOLD. THUS, THIS IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. IT WILL CONTINUE TO BE MONITORED. THEREFORE, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO FAILED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588921 DYNANAIL DYNANAIL, 10 X 220MM HSB MEDSHAPE, INC. D0108B M97012000110220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other 1200-02-5030 LOT: C6259| 1200-02-5035 LOT: C6260A| 1200-02-5045 LOT: C6239B| 1200-03-5080 LOT: P0021B