BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNACLIP 2-LEG STAPLE

    MDR report key: 18682059 · Received February 9, 2024

    Report

    Report Number
    3007593722-2024-00001
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 6, 2024
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    PMA / PMN Number
    K181781
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN CONCLUSION, THIS INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE STAPLE BREAKAGE WAS THAT THE REV. 01 DESIGN OF ED-10697.[TAB] 2 LEG DYNACLIP STAPLE AND REV. 01 DESIGN OF ED-10869. [TAB] DID NOT OPTIMIZE EVEN DISTRIBUTION OF STRAIN ACROSS THE LEGS DURING HIGH STRESS LOADING CONDITIONS. REVIEW OF THE IMAGING PROVIDED SHOWS THAT THE BREAKAGE IN THIS STAPLE OCCURRED IN THE GENERAL REGION WITH THE HIGHEST FOR POTENTIAL STRAIN ON THE LEG AS WAS DETERMINED IN CRO-2021-0081 FEA MAXIMUM LOADING CONDITION ANALYSIS. WHILE NO INJURIES, INCIDENTS OR PAIN WAS REPORTED BETWEEN THE TIME OF ORIGINAL IMPLANTATION TO THE TIME OF THE REPORTED OF STAPLE BREAKAGE, IT CAN BE CONCLUDED THE 1 OR MORE EVENTS MAY HAVE OCCURRED IN THE PATIENT POST-OPERATIVELY THAT WERE SIMILAR TO THE MAXIMUM LOADING CONDITIONS IN FEA ANALYSIS, AS THE BREAKAGE WAS IN THE LOCATION OF HIGHEST POTENTIAL STRAIN CONCENTRATION. FOLLOWING MANUFACTURING OF THE COMPLAINT STAPLE UNIT, THE DESIGN OF BOTH THE 2-LEG STAPLE (ED-10697) AND THE 4 LEG INLINE STAPLE (ED-10869) WERE REVISED FROM REV. 01 TO REV. 02 UNDER CRO-2021-0081. AS THIS EVENT HAD REPORTED PATIENT PAIN, REQUIRING REMOVAL OF THE BROKEN STAPLE, A 30-DAY MDR REPORT WAS FILED TO FDA AS PER QS-8.2.1.7, SOP, MEDICAL DEVICE REPORTING. QSF-8.2.1.2, HEALTH RISK ASSESSMENT FORM WAS COMPLETED AND APPROVED FOR THIS COMPLAINT, WHICH DETERMINED THAT NO MARKET RECALL / REMOVAL WAS NECESSARY. THE OCCURRENCE RATE OF STAPLES BREAKING WITH A CAUSE ATTRIBUTABLE TO THE OLD REVISION DESIGN IS APPROXIMATELY (B)(4). DESPITE THE STAPLE BREAKAGE AND REMOVAL, BOTH STAPLES FUNCTIONED PROPERLY TO FACILITATE FULL BONE FUSION. AS THE DESIGN CHANGE TO IMPROVE THE STRAIN PROFILE OF DYNACLIP 2-LEG AND 4-LEG STAPLES HAS BEEN COMPLETED IN MAY 2021, NO FURTHER CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME FOR THE REASONS LISTED ABOVE AND BASED ON COMPLETED HEALTH RISK ASSESSMENT FORM QSF-8.2.1.2.

    Additional Manufacturer Narrative · 0

    ON (B)(6), CUSTOMER NOTIFIED MEDSHAPE OF 1 BROKEN DYNACLIP 2-LEG STAPLE THAT REQUIRED REMOVAL FROM THE PATIENT DUE TO REPORTED PAIN. THE ORIGINAL SURGERY WAS COMPLETED ON THIS PATIENT ON (B)(6) 2021 AND THE STAPLE FUNCTIONED SUCCESSFULLY TO FUSE THE IMPACTED BONES. ALL ADDITIONAL INFORMATION FOR EXACT PART NUMBER, SIZE AND LOT NUMBER OF THE STAPLE WAS UNAVAILABLE AT THE TIME OF THE REPORT. REMAINING SPECIFICS OF STAPLE IMPLANT, CASE INFORMATION, PATIENT NOTES, OPERATIVE NOTES, AND INFORMATION TO DETERMINE CONCLUSIVE CAUSE IS UNKNOWN AT THIS TIME AND MULTIPLE REQUESTS HAVE BEEN MADE TO OBTAIN INFORMATION NEEDED FOR INVESTIGATION. THE DEVICE FAILURE, WHICH RESULTED IN PATIENT PAIN AND REMOVAL, FITS THE CATEGORY REQUIRING A 30-DAY MDR TO REPORT PER QS-8.2.1.3, SOP, MEDICAL DEVICE REPORTING. IN RESPONSE TO THIS EVENT, QSF-8.2.1.2, HEALTH RISK ASSESSMENT FORM HAS BEEN COMPLETED. BASED ON REVIEW OF IMAGES OF BROKEN STAPLES, A POTENTIAL FAILURE MODE AND ROOT CAUSE HAVE BEEN IDENTIFIED. GIVEN THE POTENTIAL ROOT CAUSE (STILL TO BE CONFIRMED PENDING RECEIPT OF ADDITIONAL INFORMATION), HEALTH RISK AND FAILURE MODE ANALYSIS IN QSF-8.2.1.2 HAVE IDENTIFIED THAT THE LIKELIHOOD OF THIS SAME MANNER OF STAPLE BREAKAGE OCCURRING IN THE FIELD IS EXTREMELY UNLIKELY, COUPLED WITH AN EXTREMELY HIGH SUCCESS RATE OF THESE STAPLES, NO FIELD ACTION OR MARKET REMOVAL IS NECESSARY FOR THIS COMPLAINT. A SUPPLEMENTAL MDR REPORT WILL BE FILED FOR COMPLAINT 24-01-008 WHEN ALL NECESSARY INFORMATION HAS BEEN OBTAINED AND THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6), CUSTOMER NOTIFIED MEDSHAPE OF 1 BROKEN DYNACLIP 2-LEG STAPLE THAT REQUIRED REMOVAL FROM THE PATIENT DUE TO REPORTED PAIN. THE ORIGINAL SURGERY WAS COMPLETED ON THIS PATIENT IN (B)(6) 2021 AND THE STAPLE FUNCTIONED SUCCESSFULLY TO FUSE THE IMPACTED BONES. ALL ADDITIONAL INFORMATION FOR EXACT PART NUMBER, SIZE AND LOT NUMBER OF THE STAPLE WAS UNAVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82796 DYNACLIP 2-LEG STAPLE STAPLE, FIXATION, BONE JDR MEDSHAPE, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other