BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO GRASPER PEN 35 UP *EA

    MDR report key: 10610711 · Received September 30, 2020

    Report

    Report Number
    1221934-2020-02819
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 15, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    NBH
    UDI-DI
    10886705003846
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING WITH THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE DOCTOR TRIED TO OPEN THE JAW OF THE PENETRATING GRASPER, HEARD A CLICK AND THE HANDPIECE MOVED, HOWEVER, THE JAW DID NOT. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION REVEALED THAT THE DEVICE IS IN NORMAL USE CONDITION. A LITTLE GREEN LABEL COULD BE OBSERVED AT THE BEGINNING OF THE SHAFT. WHEN PERFORMING THE FUNCTIONAL TEST, THE HANDLE WAS OPENED AND CLOSED SEVERAL TIMES, HOWEVER THE JAWS DID NOT OPEN OR CLOSE. THE JAWS ARE LOOSE FROM THE CONNECTING PIN THAT COMES FROM THE HANDLE. ACCORDING WITH THE FUNCTIONAL TEST RESULT, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE REPORTED CONDITION CAN BE ATTRIBUTED TO THE AGE AND HARD USE OF THE DEVICE. SINCE THIS DEVICE IS REUSABLE, THE METAL BEGINS TO LOSE IT'S SHAPE DUE TO THE CONTINUOUS USE CAUSING WEAR OF INTERNAL COMPONENTS. HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [19J02] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EVENT OCCURRED DURING A BICEPS TENODESIS PROCEDURE. H6: METHOD CODES: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [19J02] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT THE DOCTOR TRIED TO OPEN THE JAW OF THE PENETRATING GRASPER, HEARD A CLICK AND THE HANDPIECE MOVED, HOWEVER, THE JAW DID NOT. THEY OPENED ANOTHER SET WITH ANOTHER PENETRATING GRASPER TO FINISH THE CASE. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070271 ARTHRO GRASPER PEN 35 UP *EA SUTURE/NEEDLE PASSER, REUSABLE NBH DEPUY MITEK LLC US 214601 19J02 10886705003846

    Patients

    Seq Age Sex Outcome Treatment
    1