WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO

Additional Manufacturer Narrative

THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT TWO WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO WERE USED IN A SURGERY ON (B)(6) 2016. IT WAS ALSO REPORTED: "THIS PRODUCT FELL APART AND STAYED IN BODY OF PATIENT." BOTH THE PRODUCTS ARE FOUND TO BE DEFECTIVE. THE SURGERY WAS DELAYED FOR 40 MINUTES. PATIENT RETAINED A FOREIGN BODY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

Additional Manufacturer Narrative

THE MANUFACTURER RECEIVED 3 WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO WITH SAME LOT NUMBER FOR INVESTIGATION ON OCTOBER 26, 2016. THE INVESTIGATION IS PENDING. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem

IT HAS NOW BEEN REPORTED THAT THREE WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO WERE USED IN A SURGERY ON (B)(6) 2016. IT WAS ALSO REPORTED: "THIS PRODUCT FELL APART AND STAYED IN BODY OF PATIENT." BOTH THE PRODUCTS ARE FOUND TO BE DEFECTIVE. THE SURGERY WAS DELAYED FOR 40 MINUTES. PATIENT RETAINED A FOREIGN BODY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 8, 2017: IT WAS NOW EXPLAINED THAT ONLY ONE WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO WAS INVOLVED IN THIS SURGERY. THE TWO OTHER DEVICES RECEIVED BY THE MANUFACTURER WERE INVOLVED IN OTHER SURGERIES WITH DIFFERENT PATIENTS AND TWO NEW CASES WERE THEREFORE OPENED ((B)(4)). THE INVESTIGATION IS PENDING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem

IT HAS NOW BEEN REPORTED THAT A WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO WAS USED IN A SURGERY ON (B)(6) 2016. IT WAS ALSO REPORTED: "THIS PRODUCT FELL APART AND STAYED IN BODY OF PATIENT." THE SURGERY WAS DELAYED FOR 40 MINUTES. PATIENT RETAINED A FOREIGN BODY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT HAS BEEN CORRECTED: ONLY ONE INSTRUMENT WAS INVOLVED DURING THIS SURGERY (PREVIOUSLY REPORTED AS THREE INSTRUMENTS INVOLVED).

Additional Manufacturer Narrative

TREND ANALYSIS: A TREND HAS BEEN IDENTIFIED AND AN ISSUE EVALUATION HAS BEEN INITIATED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. 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. (B)(4).