IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE EXP DATE IS CURRENTLY UNAVAILABLE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 228143, LOT 155821R COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS REPORT IS BEING FILED FROM THE (B)(4) COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.
D
Patient 1
THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR THAT TWO OF THE CUSTOMER'S OMNISPAN MENISCAL REPAIR SYSTEM 12 DEGREE NEEDLES WOULD NOT DEPLOY THE 2ND IMPLANT. IN BOTH CASES THE FIRST IMPLANT WAS REMOVED, LEAVING THE MENISCUS UNDAMAGED. THE SURGEON COMPLETED THE PROCEDURE WITH A 2ND OMNISPAN MENISCAL APPLIER AND TWO MORE SAME LIKE IMPLANTS WITH NO PATIENT CONSEQUENCES. THERE WAS A FIVE MINUTE DELAY REPORTED. THE SALES REP REPORTED THAT THE SURGEON PLACED THE TWO OTHER IMPLANTS SLIGHTLY OVER WHERE HE INITIAL IMPLANTS HAD BEEN PLACED AND THAT IT WAS A LARGE TEAR ALLOWING FOR THE PLACEMENT AND SECURING THE FIXATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.