1392 5.9MM STRYKER SHEATH 2 WAY -NS

Additional Manufacturer Narrative

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: AFTER MULTIPLE ATTEMPTS TO RETRIEVE DEVICE RETURN INFORMATION, NO INFORMATION WAS PROVIDED, THEREFORE DEVICE WILL NOT BE AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. IT WAS REPORTED THAT THE DEVICE WAS LEAKING DUE TO DAMAGE O-RINGS. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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

IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A KNEE ARTHROSCOPY PROCEDURE THE CUSTOMER'S 5.9MM STRYKER SHEATH 2-WAY IS 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.

Additional Manufacturer Narrative

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. INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE THE CUSTOMER'S 5.9MM STRYKER SHEATH 2-WAY IS 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. AFTER MULTIPLE ATTEMPTS TO RETRIEVE DEVICE RETURN INFORMATION, NO INFORMATION WAS PROVIDED, THEREFORE DEVICE WILL NOT BE AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. IT WAS REPORTED THAT THE DEVICE WAS LEAKING DUE TO DAMAGE O-RINGS. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A 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. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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.