OFFSET REAMER WITH AO HANDLE, 4 STRUTS

Additional Manufacturer Narrative

TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: UNSTABLE CONNECTION TO REAMER. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A CONCESSION WAS FOUND THAT HAS NO EFFECT ON THE EFFECTIVENESS OF THE PRODUCT. EVENT SUMMARY: IT WAS REPORTED THAT THE CONNECTION BETWEEN THE REAMER AND THE REAMER HANDLE WAS UNSTABLE AND GOT LOOSE. NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. VISUAL EXAMINATION: THE WHOLE INSTRUMENT WAS RETURNED. THE VISUAL EXAMINATION SHOWS NO BREAKAGE OF THE DEVICE. NO RELEVANT DAMAGES/DEFORMATIONS CAN BE SEEN. HOWEVER, SEVERAL SIGNS OF USAGE ARE VISIBLE. - FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED. A HEMISPHERIC REAMER (REF 01.000209.470, LOT 12.776264) WAS CONNECTED TO THE INSTRUMENT AND THE CONNECTION SEEMED STABLE. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE. NOT POSSIBLE -> DESIGN CHANGES HAVE BEEN PERFORMED FOR THIS INSTRUMENT, HOWEVER TO COPE WITH A DIFFERENT FAILURE MODE: BREAKAGE /DEFORMATION OF THE SHAFT. A SYSTEMATIC ISSUE WITH DESIGN WHICH LEADS TO CONNECTION ISSUE TO THE MILLING TOOL WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO FAILURE OF INSTRUMENT MATING CONDITION => POSSIBLE, AS IT IS UNKNOWN WHICH REAMER WAS USED IN THE SURGERY. IT IS REPORTED THAT NO STABLE CONNECTION COULD BE ARCHIVED. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. MOREOVER, THE INSTRUMENT MIGHT HAVE BEEN ON THE MARKET FOR UP TO 10 YEARS AND THEREFORE A DETERIORATION IN FUNCTION DUE TO REPEATED USE IS POSSIBLE. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - INSTRUMENT CANNOT BE USED WITH THE CONNECTED INSTRUMENT AS INTENDED DUE TO FAILURE OF INSTRUMENT ASSEMBLY CONDITION => POSSIBLE, AS IT IS UNKNOWN WHICH REAMER WAS USED IN THE SURGERY. IT IS REPORTED THAT NO STABLE CONNECTION COULD BE ARCHIVED. CONCLUSION SUMMARY THE INSTRUMENT WAS RETURNED FOR AN INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED, AND THE CONNECTION BETWEEN CHANA REAMER HANDLE AND THE REAMER SEEMED STABLE. AS THE INSTRUMENT WAS MANUFACTURED IN 2007 IS MIGHT HAVE BEEN ON THE MARKET FOR ALMOST 10 YEARS AND USED EXCESSIVELY. THE EVENT COULD NOT BE RECREATED. HOWEVER, IT IS POSSIBLE THE DUE TO THE EXCESSIVE USAGE OF THE INSTRUMENT OVER MANY YEARS AND THE APPLICATION OF UNUSUAL HIGH FORCES, THE CONNECTION TO THE REAMER LOOSENED. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION BECAME AVAILABLE AND IS FILLED IN THIS REPORT. 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 WAS REPORTED THAT THE OFFSET REAMER WITH AO HANDLE, 4 STRUTS COULD NOT HOLD THE SHAFT FIRMLY IN THE COUPLING AND THEY CAME OFF.

Additional Manufacturer Narrative

THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION YET, HOWEVER IT IS MENTIONED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AT COMPLAINANT ON APRIL 21, 2017. 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. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE REAMER/CUTTER SHAFT (CATALOG AND LOT NUMBER UNKNOWN) COULD NOT HOLD THE SHAFT FIRMLY IN THE COUPLING AND THEY CAME OFF. THIS IS THE ONLY INFORMATION REPORTED AT THE TIME BEING.