CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AO

Additional Manufacturer Narrative

INVESTIGATION OF THE CASE WITH FOLLOWING OUTCOME: A TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FRACTURED INSTRUMENT. DEVICE HISTORY RECORDS (DHR): THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE INFORMATION WAS REQUESTED AND IS CURRENTLY NOT AVAILABLE. EVENT DESCRIPTION (EVENT DETAILS, PER) EVENT SUMMARY: IT WAS REPORTED THAT THE TIP OF THE REAMER HAS FRACTURED DURING USE. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS NO PRODUCT WAS RECEIVED AT ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, IT IS DISCARDED AT THE HOSPITAL. REVIEW OF PRODUCT DOCUMENTATION PRODUCT HISTORY: THE LOT NUMBER OF THIS INSTRUMENT REMAINS UNKNOWN. IT WAS FOUND THAT THERE IS A FIELD ACTION (FA 2018-05, ZFA 2018-00135) FOR THREE LOTS (14935, 15039 AND 15393) OF THIS PART NUMBER. IT WAS FOUND THAT THE MATERIAL OF THESE LOTS HAS NOT BEEN ACCORDING TO SPECIFICATION. AN INCORRECT (SOFTER) RAW MATERIAL HAS BEEN USED, WHICH COULD LEAD TO A POTENTIAL BREAKAGE OF THE INSTRUMENT. THIS FIELD ACTION HAS BEEN INITIATED IN MAY 2018, AFTER THE EVENT DATE OF THIS COMPLAINT. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: BREAKAGE OF INSTRUMENT DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE = POSSIBLE, AS THE LOT NUMBER REMAINS UNKNOWN, IT CANNOT BE DETERMINED WHETHER THE MATERIAL IS ACCORDING TO SPECIFICATION. DETERIORATION IN FUNCTION DUE TO WRONG MAINTENANCE = POSSIBLE, AS A DETERIORATION IN FUNCTION AS A RESULT OF REPEATED USE CANNOT BE EXCLUDED. MALFUNCTION, INSUFFICIENT DEVICE PERFORMANCE OR DURABILITY DUE TO 1) USER´S DISREGARD OF MANUFACTURER´S RECOMMENDATION 2) USE ERROR (SLIPS, LAPSES, MISTAKES, REASONABLY FORESEEABLE MISUSE) 3) ABNORMAL USE BEYOND RISK CONTROL = POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. FAILURE OF SURGERY DUE TO USE OF THE DEVICE NOT COMPLIANT WITH DEFINED INDICATIONS = POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. FAILURE OF SURGERY DUE TO WRONG SELECTION OF COMPONENTS OR USE IN COMBINATION WITH DEVICE OUTSIDE THE SYSTEMS = POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. DYSFUNCTIONALITY / MALFUNCTION OF DEFECTIVE DEVICES AND INSTRUMENTS DUE TO MISHANDLING OF DEVICE BY USER = POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. CONCLUSION SUMMARY: THE INSTRUMENT HAS NOT BEEN RECEIVED FOR AN INVESTIGATION, THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. AS THE LOT NUMBER IS UNKNOWN, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. IT WAS FOUND THAT THERE IS A FIELD ACTION FOR THREE LOTS (14935, 15039 AND 15393) OF THIS PART NUMBER. IT WAS FOUND THAT THE MATERIAL OF THESE LOTS HAS NOT BEEN ACCORDING TO SPECIFICATION. AN INCORRECT (SOFTER) RAW MATERIAL HAS BEEN USED, WHICH COULD LEAD TO A POTENTIAL BREAKAGE OF THE INSTRUMENT. THIS FIELD ACTION HAS BEEN INITIATED IN MAY 2018, AFTER THE EVENT DATE OF THIS COMPLAINT. AS THE CONCERNED LOTS HAVE NOT BEEN DELIVERED IN TO THE USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION IT CANNOT BE DETERMINED WHETHER THE COMPLAINED INSTRUMENT IS ALSO AFFECTED BY THIS FIELD ACTION OR WHETHER THE BREAKAGE IS DUE TO A DIFFERENT ROOT CAUSE. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Additional Manufacturer Narrative

THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON APRIL 05, 2018 TO THE APPROPRIATE REPRESENTATIVES. LOT NUMBER OF THE INSTRUMENT. DETAILS OF PATIENT INVOLVED IN THE SURGERY. HOW MANY TIMES WAS THE INSTRUMENT USED? 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 BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THE CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AO FRACTURED AND THE SURGERY WAS COMPLETED BY ANOTHER SIMILAR DEVICE WITH A DELAY OF 5 MIN. IT WAS ALSO REPORTED THAT NO BROKEN PIECES REMAINED INSIDE PATIENT. NOTE: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.