BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINCISE AUTOMATED SURGICAL IMPACTOR

    MDR report key: 12615881 · Received October 12, 2021

    Report

    Report Number
    1045834-2021-01650
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    September 30, 2021
    Report Date
    September 30, 2021
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    00850915006006
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: THE SERIAL NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN, AND THE UDI IS INCOMPLETE. UDI: SERIAL NUMBER UNKNOWN; (B)(4) UNKNOWN(21)UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING A HIP SURGERY, IT WAS DISCOVERED THAT WHILE BROACHING THE STEM WITH THE IMPACTOR DEVICE, THE SURGEONS PERFORMED A REPOSITIONING AND REALIZED THAT THERE WAS A THREE MILLIMETER (3MM) OF TOO MUCH LEG LENGTH, AND SO THEY DECIDED TO PUT THE BROACH A LITTLE DEEPER INTO THE PATIENTS FEMUR. THE REPORTER INDICATED THAT THE SURGEONS ACCOMPLISHED THE TASK BY USING THE IMPACTOR WITHOUT APPLYING FORCE. IT WAS FURTHER REPORTED THAT IN ONE MOMENT, THE DEVICE CRACKED THE FEMUR. ACCORDING TO THE REPORTER, THERE WAS A LONG CRACK APPROXIMATELY TEN CENTIMETERS (10CM) LONG, AS A RESULT, A 2X CERCLAGE AND A CEMENTED STEM WAS PUT IN. IT WAS REPORTED THAT THE PLAN WAS TO OPERATE BOTH SIDES OF THE LEG; HOWEVER, DUE TO THE LONG DELAY IN SURGERY AND THE RISK OF THE PATIENT TO LATER APPLY TOO MUCH FORCE ON THE OTHER LEG, IT WAS DECIDED TO COMPLETE ONLY ONE SIDE. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS GENERATED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS FORTY-FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE REPORTS OF INJURIES, MEDICAL INTERVENTION AND/OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE INCISION HAD TO BE EXTENDED, POST-OPERATION TREATMENT HAD TO BE ADAPTED, THE CRACK IN THE LEG HAD TO BE CEMENTED, AND THE SECOND SIDE OF THE LEG WAS NOT OPERATED ON AND HAD TO BE POSTPONED TO A LATER TIME. IT WAS FURTHER REPORTED THAT THE BONE QUALITY WAS NOT AS GOOD AS EXPECTED FROM THE X-RAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514218 KINCISE AUTOMATED SURGICAL IMPACTOR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC 00850915006006

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R