HEMICAP® TOE DF & TOEMOTION® IMPLANT SYSTEMS

Additional Manufacturer Narrative

THE COMPLAINT IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION AND / OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

Description of Event or Problem

ON (B)(6) 2022 IT WAS REPORTED TO ARTHROSURFACE ((B)(4)) THAT A GUIDEWIRE BEND WHILE BEGINNING TO DRILL ON A MALE PATIENT OF UNKNOWN AGE AND DEMOGRAPHICS. THE PROCEDURE WAS THE FIRST METATARSAL TOTAL TOE RESURFACING PROCEDURE. THE GUIDEWIRE WAS DEEMED UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME LOT AND PRODUCT CODE. THERE WAS NO PATIENT IMPACT REPORTED. ON (B)(6) 2022 ARTHROSURFACE ((B)(4)) RECEIVED A MEDWATCH REPORT (MW5108762) FROM THE FDA MEDWATCH. THE CASE WAS REASSESSED AS A REPORTABLE EVENT DUE TO THE RECEIPT OF THE MEDWATCH REPORT. ADDITIONAL INFORMATION WAS SOLICITED.

Additional Manufacturer Narrative

THE COMPLAINT IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION AND / OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. THE REPORTED EVENT IS NOT CONFIRMED. ADDITIONAL INFORMATION AND PHOTOS OF THE DEVICE WAS SOLICITED BUT NOT PROVIDED BY THE COMPLAINANT. IT WAS REPORTED TO (B)(6) THAT THE GUIDEWIRE WAS BENT WHILE BEGINNING TO DRILL ON A MALE PATIENT AND THE GUIDEWIRE WAS DEEMED UNUSABLE. THERE WAS NO NEGATIVE PATIENT IMPACT, AND THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER UNIT OF THE SAME PRODUCT/LOT CODE AND CONTINUED IN NORMAL FASHION. THE DEVICE HISTORY RECORD (DHR) RELATED TO THE ARTHROSURFACE IDENTIFIED BATCH RECORD, 75EA0441, FOR FIXATION COMPONENT, Ø 13.6 MM, PHALANGEAL P/N 9P15-S180-W HAS BEEN REVIEWED BY THE MANUFACTURER OF THE DEVICE AT PRIMO MEDICAL GROUP. THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW SHOW ALL IN- PROCESS AND FINAL RELEASE TESTING WERE PERFORMED IN ACCORDANCE WITH THE APPROPRIATE PROCEDURES. ALL MATERIAL AND PROCESS CERTIFICATIONS WERE PRESENT AND CORRECT. THERE WERE NO COMPONENT LEVEL NCMR (NON-CONFORMING MATERIAL REPORTS) OR CUSTOMER DEVIATION REQUESTS IDENTIFIED. PERSONNEL WERE CHECKED FOR TRAINING RECORDS AND EXPERIENCE ON THE LINE. ALL OPERATORS WERE EXPERIENCED AND TRAINED ON THE PROCESS. A ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION.

Description of Event or Problem

ON 31MAR2022 IT WAS REPORTED TO ARTHROSURFACE (ANIKA) THAT A GUIDEWIRE BEND WHILE BEGINNING TO DRILL ON A MALE PATIENT OF UNKNOWN AGE AND DEMOGRAPHICS. THE PROCEDURE WAS THE FIRST METATARSAL TOTAL TOE RESURFACING PROCEDURE. THE GUIDEWIRE WAS DEEMED UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME LOT AND PRODUCT CODE. THERE WAS NO PATIENT IMPACT REPORTED. ON 28APR2022 ARTHROSURFACE (ANIKA) RECEIVED A MEDWATCH REPORT (MW5108762) FROM THE FDA MEDWATCH. THE CASE WAS REASSESSED AS A REPORTABLE EVENT DUE TO THE RECEIPT OF THE MEDWATCH REPORT. ADDITIONAL INFORMATION WAS SOLICITED.