WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO

Additional Manufacturer Narrative

TREND ANALYSIS: A TREND HAS BEEN IDENTIFIED AND AN ISSUE EVALUATION HAS BEEN INITIATED. EVENT SUMMARY: IT WAS REPORTED THAT THIS PRODUCT FELL APART AND STAYED IN BODY OF PATIENT. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS VISUAL EXAMINATION: THREE BROKEN INSTRUMENTS WERE RETURNED FOR INVESTIGATION. THE BROKEN PIECES WERE NOT RETURNED. IT WAS REPORTED THAT THE BROKEN PIECES STAYED IN PATIENT'S BODY. ON THE RETURNED INSTRUMENTS IT CAN BE SEEN THAT THE TIP IS BROKEN. THE LENGTH OF THE BROKEN TIP IS APPROXIMATELY 1MM. NO FURTHER ABNORMALITIES CAN BE DETECTED. THE OUTER DIAMETER OF THE RETURNED INSTRUMENTS WAS MEASURED WITH A CALIPER. ONE INSTRUMENT COULD NOT BE MEASURED AS THE BREAKAGE AREA IS DEFORMED AND NO MEANINGFUL MEASUREMENT CAN BE TAKEN. FOR THE OTHER INSTRUMENTS THE MEASUREMENTS ARE WITHIN THE REQUIRED SPECIFICATION. - IN ADDITION, A FUNCTIONAL CHECK OF THE CANNULATION WAS DONE WITH INSPECTION PINS. THE INNER DIAMETER (ACCORDING TO PRODUCT DRAWING 1.0 0/+0.1) WAS TESTED WITH AN INSPECTION PIN 1.0 AND INSPECTION PIN 1.1. THE INSPECTION PIN 1.0 DID PASS IN ALL THREE INSTRUMENTS WHEREAS THE INSPECTION PIN 1.1 WENT NOT THROUGH THE CANNULATION. THE FUNCTION OF THE INNER DIAMETER (CANNULATION) IS THEREFORE GIVEN. CONCLUSION SUMMARY THE RESEARCH DEPARTMENT PERFORMED A HARDNESS-TEST AND A CHEMICAL ANALYSIS OF 3 RETURNED INSTRUMENTS. THE INVESTIGATIONS RELATED TO HARDNESS SHOWED THAT THE MATERIAL INVESTIGATED IS HARDER THAN IT IS SUPPOSED TO BE ACCORDING TO THE DRAWING. THE INVESTIGATIONS FROM RESEARCH DEPARTMENT CAME TO THE CONCLUSION THAT A MATERIAL MIX-UP MUST HAVE OCCURRED AT THE SUPPLIER WHO WAS MANUFACTURING THE DEVICES. THE RECEIVED RAW MATERIAL SPECIFICATION FROM THE SUPPLIER DESCRIBES THAT A MATERIAL 1.4028 WAS USED. RESEARCH DEPARTMENT ALSO PROVIDED A CONCLUSION THAT WITH A VERY HIGH LIKELIHOOD THE USED MATERIAL FOR MANUFACTURING WAS 1.4112 (ACCORDING TO HARDNESS-TESTS, CHEMICAL ANALYSIS AND MATERIAL-MICROSTRUCTURE). MATERIAL 1.4112 IS A BIOCOMPATIBLE MEDICAL GRADE STAINLESS STEEL USED E.G. FOR DRILL BITS. HOWEVER, CORRECTIVE AND PREVENTIVE ACTIONS HAVE ALREADY BEEN INITIATED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

Additional Manufacturer Narrative

THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE INVESTIGATION IS PENDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO WAS USED IN A SURGERY ON (B)(6) 2016. THIS PRODUCT BROKE DURING SURGERY AND A PIECE REMAINED IN PATIENT'S BODY. THERE IS NO MEDICAL INTERVENTION. NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.