BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINCISEA AUTOMATED SURGICAL IMPACTOR

    MDR report key: 11946646 · Received June 7, 2021

    Report

    Report Number
    1045834-2021-00905
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 19, 2021
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    07611819977846
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. H10 ADDITIONAL NARRATIVE: DEVICE HISTORY RECORD SHOWS THE LOT OF 1000-00-101 PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. REPORTER¿S COMPLETE MAILING ADDRESS IS UNKNOWN. REPORTER¿S PHONE NUMBER IS UNKNOWN. CONCOMITANT MEDICAL DEVICES AND THERAPY DATES: BROACH ADAPTOR DEVICE, BROACH DEVICES; (B)(6) 2021. UDI: (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A TOTAL HIP ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ADAPTOR DEVICE COULD NOT BE REMOVED FROM THE IMPACTOR DEVICE. ACCORDING TO THE REPORTER, THE IMPACTION WAS BEING PERFORMED FROM SIZE 8 BROACH BY ATTACHING THE BROACH ADAPTER TO THE SURGICAL IMPACTOR DURING BROACHING. AFTER REACHING THE SIZE 10 BROACH, THE SURGICAL IMPACTOR ADAPTER DEVICE COULD NOT BE REMOVED WHEN THE SURGEON TRIED TO REMOVE IT FROM THE BROACH. IT WAS NOTED THAT THERE WERE NO PROBLEMS FROM SIZE 8 TO 9 BROACHES, HOWEVER FROM SIZE 10, THE BROACH COULD NOT BE ATTACHED. DUE TO THIS, THE LEVER OF THE BROACH WAS OPENED AND SLIGHTLY PULLED, AND IMPACT WAS APPLIED ONCE WITH SURGICAL IMPACTOR ADAPTER AND THE DEVICE COULD THEN BE REMOVED. AFTER THAT, THE SURGEON TRIED TO ATTACH THE SURGICAL IMPACTOR ADAPTER DEVICE TO THE BROACH AGAIN, BUT THE NECK OF THE BROACH DID NOT GO INTO THE BROACH ADAPTER AND COULD NOT BE ATTACHED. THEREFORE, THE SURGEON REPLACED IT WITH AN ANTERIOR BROACH HANDLE AND MANUALLY REMOVED THE SIZE 10 BROACH. SIZE 11 BROACHES WERE THEN MANUALLY INSERTED. AFTER AN ATTEMPTED REDUCTION, A STEM 11 IMPLANT WAS INSERTED. IT WAS FURTHER REPORTER THAT THE POSTOPERATIVE X-RAY SHOWED A FRACTURE LINE IN THE MIDDLE OF THE STEM. AS A RESULT, THE OPERATION WAS COMPLETED AFTER RE-OPENING THE WOUND AND ROLLING 3 NESPRON CABLES AROUND THE FRACTURE SITE. IT WAS REPORTED THAT THE SURGERY WAS SCHEDULED TO TAKE ABOUT TWO AND A HALF HOURS, HOWEVER DUE TO A FRACTURE BEING FOUND IN THE POST OPERATIVE X-RAY, TREATMENT FOR THE FRACTURE WAS PERFORMED. THE FINAL SURGERY TOOK ABOUT FIVE HOURS. THERE WERE NO ALLEGATIONS OF MALFUNCTION AGAINST THE SURGICAL IMPACTOR DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845290 KINCISEA AUTOMATED SURGICAL IMPACTOR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC 07611819977846

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention