IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4) - INCOMPLETE. THE LOT NUMBER IS CURRENTLY UNAVAILABLE; THEREFORE, THE EXP DATE IS UNAVAILABLE. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION AND THEREFORE A ROOT CAUSE FOR THIS FAILURE CANNOT BE DISCERNED. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY 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 FROM THE ETQ 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 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER STABILIZATION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE SHUTTLE KITE BROKE, THEN ANOTHER ONE WAS OPENED. ACCORDING TO THE REPORTER, THE TIP OF THE BIOKNOTLESS ANCHOR BROKE OFF IN THE JOINT SPACE OF THE PATIENT. IT WAS FURTHER REPORTED THAT WHEN THE SECOND BIOKNOTLESS ANCHOR WAS USED, THE INSERTER BENT AT THE JOIN OF THE SHOULDER. THE TIP OF THE INSERTER THEN BROKE OFF IN THE PATIENT AS IT WAS BEING PULLED OUT. THE ONE CENTIMETER METAL PIECE OF THE ANCHOR GOT STUCK IN THE JOINT SPACE OF THE PATIENT AND THE SURGEON WAS UNABLE TO RETRIEVE IT. THE SURGEON HAD TO CHANGE FROM AN ARTHROSCOPIC SURGERY TO AN OPEN SURGERY, AND WORKED FOR ONE TO TWO HOURS IN ORDER TO REMOVE THE METAL PIECE. THE OBJECT WAS EVENTUALLY REMOVED WITH ANOTHER SURGEON ASSISTANCE. THERE WAS A 180 MINUTE DELAY TO SURGERY. IT WAS REPORTED THAT THE PATIENT OUTCOME POST SURGERY WAS SUBOPTIMAL. 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.