HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

BASED ON THE REPORTER'S INFORMATION, BROKEN PIECES OF GUIDE PINS WERE LEFT INSIDE THE PATIENT'S KNEE. HOWEVER, THE GUIDE PINS ARE MADE FROM IMPLANTATION GRADE SURGICAL STEEL COMPLIANT TO ASTM-F-138 STANDARD. SO, THERE WOULDN'T BE ANY HARM TO THE PATIENT IF IMPLANTED OR LEFT INSIDE THE PATIENT'S KNEE. REVIEW OF QUALITY INSPECTION PLAN (QIP), DEVICE HISTORY RECORD (DHR) AND MATERIAL CERTIFICATES OF THE LOT IN QUESTION INDICATE PARTS WERE MANUFACTURED TO SPECIFICATION AND NO PARTS WERE REJECTED. ALSO, THE PARTS FROM THE SAME LOT HAVE BEEN TESTED AGAINST TWO OTHER OLDER LOTS TO VERIFY TORSIONAL STRENGTH. THE RESULTS SHOWED GREATER TORQUE VALUES THAN THE PREVIOUS LOTS AND PINS DID FUNCTION AS INTENDED. PIN KITS FROM SAME LOT (75CE1219) HAVE BEEN USED IN 27 PFXL CASES TILL DATE ((B)(6) 2016) IN US. THIS IS THE FIRST COMPLAINT AND NO REPORTS OF BROKEN PINS FROM THIS LOT HAVE BEEN RECEIVED. HERE, IT IS IMPORTANT TO NOTE THAT THE 3 SURGERIES WERE PERFORMED BY THE SAME SURGEON. IT IS POSSIBLE THAT SURGEON MIGHT HAVE USED A BIT OF EXCESSIVE FORCE THAT LED TO BREAKING OF THE GUIDE PINS. THE DISTRIBUTOR'S EMAIL THAT WAS RECEIVED ON 02/17/2016 SUGGESTS THAT EXCESSIVE FORCE WAS USED IN THE SURGERIES 1 & 2. CONSIDERING THE ABOVE POINTS, IT WAS CONCLUDED THAT THERE ARE NO CONTRIBUTING FACTORS TO THE BREAKING OF GUIDE PINS. ENGINEERING DEPARTMENT WILL REVIEW THE USE OF THREADED PINS FOR POTENTIAL REPLACEMENT WITH NON-THREADED ONES. THE COMPLAINT IS CONSIDERED CLOSED AND FURTHER INFORMATION IF AVAILABLE, WILL BE ADDED TO THE COMPLAINT FILE.

Description of Event or Problem

ON (B)(6) 2016, A (B)(4) DISTRIBUTOR CONTACTED ARTHROSURFACE TO REPORT 3 PF CASES WHERE THE SHORT GUIDE PINS (2 MM) WERE BROKEN. ALL THE PIN KITS BELONG TO THE SAME LOT AND ALL 3 CASES WERE PERFORMED BY SAME SURGEON. SINCE BROKEN PIECES WERE DIFFICULT TO RETRIEVE, THE SURGEON HAD TO LEAVE THEM IN PATIENT'S KNEE IN ALL 3 CASES. SEVERAL ATTEMPTS HAVE BEEN MADE BY ARTHROSURFACE TO OBTAIN THE DATES OF INCIDENTS. THE DISTRIBUTOR WAS UNABLE TO GET THE DATES FROM THE HOSPITAL. THOUGH THE ISSUE IS SAME IN THE 3 CASES, SEPARATE MDRS ARE BEING FILED PER MDR REQUIREMENTS. INCIDENT # 02. DATE OF INCIDENT: UNKNOWN.