BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1392 5.9MM STRYKER SHEATH 2 WAY -NS

    MDR report key: 9117750 · Received September 25, 2019

    Report

    Report Number
    1221934-2019-58504
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    July 19, 2018
    Report Date
    July 23, 2018
    Product Code
    HNX
    UDI-DI
    10886705016099
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S 5.9MM STRYKER SHEATH 2-WAY IS LEAKING DUE TO DAMAGED O-RINGS. DESPITE MULTIPLE ATTEMPTS MADE TO THE SALES REPRESENTATIVE FOR THE RETURN OF THE COMPLAINT DEVICE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE. THIS COMPLAINT CANNOT BE CONFIRMED. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS FAILURE. ACCORDING TO ATTACHED MEMO REFERENCING TO SOPRO-COMEG, AS SOPRO-COMEG GMBH MAINTAINED ALL MANUFACTURING RECORDS IN THEIR FILES AND NO RELATION HAS BEEN HELD WITH THIS COMPANY SINCE SEPTEMBER 2017, NO MANUFACTURING RECORD EVALUATION CAN BE PERFORMED FOR ALL LOTS MANUFACTURED BY SOPRO-COMEG GMBH. 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 · 1

    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. UDI: (B)(4). INVESTIGATION SUMMARY: DESPITE MULTIPLE ATTEMPTS MADE TO THE SALES REPRESENTATIVE FOR THE RETURN OF THE COMPLAINT DEVICE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE. THIS COMPLAINT CANNOT BE CONFIRMED. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS FAILURE. THIS COMPLAINT CAN BE CONFIRMED. 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. THIS REPORT IS BEING FILED AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S 5.9 MM STRYKER SHEATH 2-WAY WAS LEAKING DUE TO DAMAGED O-RINGS. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT ANY FURTHER INFORMATION. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    911124 1392 5.9MM STRYKER SHEATH 2 WAY -NS RIGID ENDOSCOPE SHEATH HNX 281392 10886705016099

    Patients

    Seq Age Sex Outcome Treatment
    1