(B)(4). DEVICE NOT IMPLANTED OR EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE 04.500.013 BROKE WHILE BEING BENT BY SURGEON DURING SURGERY. THE PLATE WAS NOT OVER BENT. SURGEON USED A NEW PLATE. FIVE MINUTES DELAY. NO ADVERSE EVENT. NO PATIENT HARM. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).
N
Patient 1
A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. SUPPLIER: MAGNUM TOOL COMPANY. RELEASE TO WAREHOUSE DATE (MANUFACTURING DATE): APR 2, 2012. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
N
Patient 1
A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS CONFIRMED AS THE RETURNED PLATE WAS RECEIVED IN TWO PIECES (PLATE SECTION WITH 4 HOLES IS SEPARATE FROM THE ANCHOR BRACKET SECTION). IN ADDITION TO BEING SHEARED IN HALF, THE RETURNED PLATE IS BENT IN SEVERAL AREAS. A THICKNESS MEASUREMENT OF 0.71MM WAS ABLE TO BE TAKEN JUST ADJACENT TO THE AREA OF PLATE BREAKAGE USING CALIPERS. PER THE RELEVANT DRAWING THE THICKNESS IS TO BE 0.70MM - 0.80MM. THEREFORE, THE PLATE THICKNESS MEASURES WITHIN SPECIFICATIONS. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE PLATE IS ALREADY BROKEN IN TWO PIECES. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY OVER-BENDING. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE RELEVANT DRAWING WAS REVIEWED DURING THIS EVALUATION. THE PLATE WAS MADE FROM COMMERCIALLY PURE GRADE 4 TITANIUM AND ANODIZED PER SPECIFICATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.