IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS THAT THE LOWER PUSHER ROD ON THE APPLIER WAS FOUND BENT AT THE DISTAL TIP WHICH MAKES IT DIFFICULT TO DEPLOY THE IMPLANT IN THE NEEDLE. WHEN TESTED FOR ITS FUNCTIONALITY, THE GREY TRIGGER WAS ROUGH TO OPERATE AND ITS GETTING STUCK IN THE MIDDLE. WHEN RED TRIGGER WAS TESTED, IT FUNCTIONS AS INTENDED. THIS COMPLAINT CAN BE CONFIRMED. THE ROOT CAUSE FOR THIS FAILURE WOULD TYPICAL BE APPLICATION OF AN EXCESS LOAD TO THE NEEDLE WHEN THE LOWER PUSH ROD IS AT DEPLOYED CONDITION. THIS FAILURE CAN BE ATTRIBUTED TO DEVICE MISUSE. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 228143, LOT 3873093 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) 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 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE WITH MENISCAL SUTURE, IT WAS OBSERVED THAT THE OMNISPAN MENISCAL REPAIR 27DEG AND MENISCAL DEPLOYMENT GUN DID NOT WORK PROPERLY WHILE IN USE TOGETHER. ACCORDING TO THE REPORTER, BOTH DEVICES DID NOT WORK ACCORDINGLY TO THEIR PURPOSES. IT WAS FURTHER REPORTED THAT DURING THE SURGERY PERFORMED, IT WAS EXPECTED TWO SHOTS OF USING THIS DEVICE BUT THE DEVICE COULD NOT PERFORMED THE SECOND SHOT (CARRIED OUT). IT WAS REPORTED THAT IT MIGHT HAVE BEEN THAT THE PISTOL BEING JAMMED. IT WAS REPORTED THAT THE FIRST IMPLANT WAS REMOVED AND DID NOT CAUSE TISSUE DAMAGE. IT WAS REPORTED THAT THE FIRST IMPLANT DID PENETRATE THE MENISCUS. IT WAS REPORTED THAT THE SURGEON USED THE SAME LOCATION TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO IMPLANTS USED AS THE SURGEON USED ANOTHER SUTURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE. 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.