BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNACLIP DELTA

    MDR report key: 23022869 · Received September 10, 2025

    Report

    Report Number
    3007593722-2025-00016
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 23, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    UDI-DI
    M970300010281614120
    PMA / PMN Number
    K220812
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS GENERATED IN RESPONSE TO A REPORT OF A DYNACLIP DELTA CASE INITIAL EXECUTED IN MARCH. THE REPORTER STATED IT WAS THE SURGEON'S FIRST DYNACLIP DELTA CASE BUT THE CASE WAS SUCCESSFUL AND THE FIRST POST-OPERATIVE X-RAYS IN MAY SHOWED NO ISSUES. HE WAS THEN SEEN IN AUGUST FOR A SCHEDULED CHECK IN AND X-RAYS REVEALED THE STAPLE HAD BROKE ALONG THE TOP OF THE STAPLE. THE PATIENT WAS NOT DIABETIC AND NEUROPATHY WAS NOT A FACTOR. THE PATIENT REPORTS NO PAIN AND IS GENERALLY HEALTHY. DUE TO THIS, THE STAPLE REMAINS IN THE PATIENT. THE REPRESENTATIVE ATTACHED 4 X-RAYS: 2 FROM THE MAY VISIT SHOWING NO BREAKAGE, AND 2 FROM AUGUST VISIT SHOWING THE BROKEN STAPLE. THE X-RAYS WERE EVALUATED AND INVESTIGATED BY THE DYNACLIP CLINICAL EXPERT AND NO FACTORS WERE IDENTIFIED BASED ON THE VISUALS AND INFORMATION PROVIDED THAT WOULD HAVE CONTRIBUTED OR HAVE CAUSED THE BREAK. THE DYNACLIP RISK MATRIX WAS REVIEWED. THE FAILURE MODE OF THE STAPLE BREAKING POST-OPERATIVELY IS RECORDED AND ACCOUNTED FOR. IN THE RISK MATRIX, THIS FAILURE MODE IS LISTED WITH THE POTENTIAL CAUSES OF FAILURE AS MANUFACTURING ERROR, IMPROPER DIMENSIONS, ABNORMAL ANATOMY CAUSES EXCESSIVE STRAINS ON THE STAPLE, OR A FAILED FUSION. IT IS UNKNOWN IF THE SURGICAL TECHNIQUE WAS ADHERED TO AS WELL AS IF THE PATIENT WAS COMPLIANT WITH THE INFORMATION PROVIDED, BUT THERE WERE NO REPORTED DEVIATIONS. WITH THE INFORMATION PROVIDED, A DEFINITIVE PROBABLE ROOT CAUSE REMAINS UNKNOWN. THE POTENTIAL FAILURE IS RANKED WITH A DETECTION SCORE OF 2, DEVICE AND PATIENT SEVERITY OF 3, AND OCCURRENCE OF 1. A HISTORICAL SEARCH WAS CONDUCTED IN THE TIMEFRAME OF (B)(6) 2024 TO (B)(6) 2025 AND RESULTS SHOWED THAT THIS WAS THE THIRD OCCURRENCE OF A COMPLAINT OR THIS FAILURE MODE OF BREAKING POST-OPERATIVELY TO THE DYNACLIP FAMILY. BASED ON A SALES VOLUME OF 3767 IN THE ABOVE-MENTIONED TIMEFRAME, THE OCCURRENCE LEVEL OF REMOTE IS APPROPRIATE, AND OVER THE YEAR, OCCURRED AT A (B)(4) RATE. 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. THE DYNACLIP RISK ANALYSIS MATRIX WAS GENERATED USING THE LEGACY MEDSHAPE RISK MANAGEMENT SOP, OCCURRENCE LEVEL COMPARISON IS IN ALIGNMENT WITH THAT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AND XRAY THE PATIENT HAD DONE IN (B)(6) 2025 SHOWED BROKEN STAPLE. THE DOCTOR DOES NOT INTEND TO REVISE AT THIS TIME AS THE PATIENT HAS NO PAIN OR IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706877 DYNACLIP DELTA DELTA DYNACLIP STAPLE, 28X16X14X12 JDR MEDSHAPE, INC. 20012 M970300010281614120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O