1392 5.9MM STRYKER SHEATH 2 WAY -NS
Received Jan 30, 2019 · Event occurred May 1, 2017
Report 1221934-2018-53724 · MDR key 8290838
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED. VISUALLY INSPECTION REVEALS THAT THE METAL COUPLER PART OF THE SHEATH WAS BROKEN OFF THE DEVICE. THE DEVICE WAS REVIEWED WITH THE DESIGN AND QUALITY ENGINEERS FOR THIS PRODUCT. THEY SAID THAT THE LASER WELD THAT HOLD THIS PART TO THE SHEATH IS BROKEN OFF. THE WELD MARKS ARE VISIBLE ON THE PARTS. THEY SUSPECT THAT THE DEVICE WAS DROPPED ON A HARD SURFACE WHICH CAUSED THIS WELD TO BREAK. THIS COMPLAINT CAN BE CONFIRMED. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THE SERIAL NUMBER OF THIS DEVICE THAT WAS RELEASED TO DISTRIBUTION. 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. UDI:(B)(4). THE SERIAL NUMBER IS NOT AVAILABLE.
Additional Manufacturer Narrative
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM 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 DURING AN UNKNOWN PROCEDURE THE 5.9 NN STRYKER SHEATH COUPLER WAS BROKEN CAUSING IT NOW TO HOLD THE LENS. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).