ADDITIONAL NARRATIVE: (B)(6). THE PRODUCT CODE IS UNKNOWN. THEREFORE, THE BRAND NAME, COMMON DEVICE NAME, CATALOG NUMBER AND 510K CLASSIFICATION ARE UNKNOWN. THE MANUFACTURING LOCATION WAS UNKNOWN. THE LOT/SERIAL NUMBER DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED FROM (B)(6) THAT AFTER SURGERY, IT WAS OBSERVED THAT AN UNKNOWN SAW BLADE DEVICE BROKE OFF AND BECAME STUCK IN THE CONNECTION POINT OF THE AIR RECIPROCATOR DEVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
N
Patient 1
THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE REAR PART OF THE SAW BLADE DEVICE WAS STUCK INSIDE THE COUPLING AND HAD TO BE REMOVED BY DISASSEMBLING THE QUICK COUPLING. IT WAS NOTED THAT THE FRONT PART OF THE SAW BLADE DEVICE WAS NOT AVAILABLE. IT WAS FURTHER DETERMINED THAT THE REAR PART OF THE SAW BLADE DEVICE IN THE SAW BLADE QUICK COUPLING WAS FIRMLY CLAMPED. DURING INVESTIGATION, THE PART OF THE SAW BLADE DEVICE WAS INSPECTED AND IT WAS DETERMINED THAT THE SAW BLADE DEVICE DID NOT MATCH THE SYNTHES SPECIFICATION (DIMENSIONS AND COATING), INDICATING THAT THE DEVICE WAS NOT PRODUCED BY SYNTHES. THE REAR PART OF THE SAW BLADE DEVICE STUCK INSIDE THE COUPLING WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.