COUPLER AC ZOOM

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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J SALES REPRESENTATIVE. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION SUMMARY THE PRODUCT HAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. ¿ THE PHOTO INVESTIGATION REVEALED THAT COUPLER AC ZOOM ARTHROSCOPIC IMAGED WAS SEEN DARK AND INCOMPLETE. ADDITIONALLY, THE DEVICE WAS SEEN CRACKED AND SCRATCHED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE COUPLER AC ZOOM WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. ¿ BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE CANNOT BE ESTABLISHED. MULTIPLE FACTORS ARE ASSOCIATED WITH THIS TYPE OF FAILURE, THE COMPLAINT DEVICE NEEDS TO BE PHYSICALLY EVALUATED IN ORDER TO DETERMINE WHY THE CUSTOMER EXPERIENCED THE FAILURE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS AND/OR THE POTENTIAL CAUSE OF THE DEFECT CANNOT BE ASSOCIATED TO MANUFACTURING.

Description of Event or Problem

IT WAS REPORTED FROM THAILAND THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVE THAT THE INTERNAL LENS OF THE COUPLER AC ZOOM DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THAT THE ARTHROSCOPIC IMAGE WAS SEEN DARK AND INCOMPLETE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: H4: THE DEVICE MANUFACTURE DATE WAS REPORTED AS UNKNOWN ON THE INITIAL REPORT. PLEASE NOTE THAT THE DATE OF MANUFACTURE HAS BEEN UPDATED ACCORDINGLY.