DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). MANUFACTURING DATE: 12OCTOBER2005. PART: 03.605.006 LOT: 5097875 (NON-STERILE) - BONE CURETTE-ANGLED/OVAL HEAD 3.5MM X 4.5MM 430MM. LOT WAS RELEASE TO THE WAREHOUSE ON (B)(6) 2005. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.
D
Patient 1
IT WAS REPORTED THAT THE TIP OF A BONE CURETTE-ANGLED/OVAL HEAD HAS A NICK. THIS INSTRUMENT WAS FROM FIELD EQUIPMENT. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURER, IT WAS NOTED THAT THE INSTRUMENT HAS BEEN RETURNED WITH A BROKEN TIP. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).
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Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 03.605.006, BONE CURETTE-ANGLED/OVAL HEAD 3.5MM X 4.5MM 430MM, LOT NUMBER 5097875). THE SUBJECT DEVICE WAS RECEIVED WITH A FADED, BUT LEGIBLE ETCH. APPROXIMATELY 1MM OF THE WIDTH OF THE CUTTING TIP IS FRACTURED OFF. THE ANGLED BONE CURETTE IS PART OF THE PROPREP DISC PREPARATION SET USED TO FACILITATE DISCECTOMY FOR ANTERIOR LUMBAR PROCEDURES PER THE TECHNIQUE GUIDE. THE LOT WAS MANUFACTURED IN OCTOBER 2005 AND IS APPROXIMATELY 10 YEARS OLD. PRODUCT DRAWINGS WERE REVIEWED DURING THE EVALUATION. THE SHAFT IS MADE FROM 420A/420B AND IS AN ADEQUATE MATERIAL FOR THE INSTRUMENTS? INTENDED USE. THIS INSTRUMENT IS SUITABLE FOR ITS INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO WHEN THIS INSTRUMENT WAS BEING USED. IT IS POSSIBLE THAT THIS INSTRUMENT WAS DROPPED ON THE FLOOR OR MISUSED. THERE IS NOT ENOUGH INFORMATION PROVIDED AND THEREFORE THIS COMPLAINT INVESTIGATION IS INDETERMINATE. A ROOT CAUSE COULD NOT BE DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.