POSTERIOR AXIAL DEVICE - TITANIUM ROMEO 2 PAD

Additional Manufacturer Narrative

AFTER WE RECEIVED THE COMPLAINT, THE DEVICE HISTORY RECORD FOLDER HAS BEEN REVIEWED. THE MANUFACTURING PROCESS AND THE QUALITY CONTROLS ARE CONFORMING TO THE SPECIFICATIONS. THERE WAS NO NON-CONFORMITY OBSERVED DURING THE MANUFACTURING PROCESS. THE INVOLVED DEVICE BELONGS TO A BATCH OF (B)(4) UNITS MANUFACTURED ON 28.MAR.2024. (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST TIME WE RECEIVE A COMPLAINT REPORTING THIS KIND OF ISSUE BEFORE WE RECEIVE THE INVOLVED DEVICE, WE DECIDED TO CHECK THE BATCH NUMBER 8-0047 AND WE ANALYZED 1 PART FROM OUR STOCK. IT IS CONFORMING TO THE SPECIFICATION; THE DEVICE WAS CORRECTLY ASSEMBLED, AND IT WAS NOT POSSIBLE TO DISASSEMBLE THE PAD OR TO MOVE A PLATE. WE ARE WAITING FOR THE EXPLANTED INVOLVED DEVICE TO INVESTIGATE.

Description of Event or Problem

ON 04 SEP 2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE (B)(4) FOLDER), FROM ITALY. THE CUSTOMER COMPLAINT FORM REPORTS THAT "PLATE DOESN'T LOCK TO TITANIUM CORE AS IT SHOULD". PLUS, WE WERE INFORMED THAT "THE SURGEON WILL HAVE TO RE OPERATE THE PATIENT, REMOVE THE PAD AND USE A NEW ONE".

Additional Manufacturer Narrative

AFTER WE RECEIVED THE COMPLAINT, THE DEVICE HISTORY RECORD FOLDER HAS BEEN REVIEWED. THE MANUFACTURING PROCESS AND THE QUALITY CONTROLS COMPLY WITH SPECIFICATIONS. THERE WAS NO NON-CONFORMITY OBSERVED DURING THE MANUFACTURING PROCESS. THE INVOLVED DEVICE BELONGS TO A BATCH OF (B)(4) UNITS MANUFACTURED ON MARCH 28, 2024. (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST TIME WE RECEIVE A COMPLAINT REPORTING THIS KIND OF ISSUE. WE RECEIVED THE POSTOPERATIVE PICTURES AND WE DID NOT IDENTIFY ANY ISSUE. BEFORE WE RECEIVE THE INVOLVED DEVICE, WE DECIDED TO CHECK THE BATCH NUMBER 8-0047 AND WE ANALYZED 1 PART FROM OUR STOCK. IT IS IN LINE WITH SPECIFICATION; THE DEVICE WAS CORRECTLY ASSEMBLED, AND IT WAS NOT POSSIBLE TO DISASSEMBLE THE PAD OR TO RELEASE A PLATE. WE RECEIVED THE INVOLVED DISASSEMBLED DEVICE ON OCTOBER 22, 2024. IT HAS BEEN REASSEMBLED BY THE R&D TEAM AND IT WAS FOUND THAT THE DEVICE WAS FUNCTIONAL, IT WAS CORRECTLY LOCKED WITHOUT ANY POSSIBILITY TO RELEASE A PLATE. WE DID NOT DETECT ANY ISSUE, THE DEVICE IS FUNCTIONAL. THE REPORTED CASE IS NOT AN INCIDENT AS IT IS NEITHER A MALFUNCTION NOR A DETERIORATION IN THE CHARACTERISTICS OR PERFORMANCE OF THE DEVICE. THE CASE IS NOT REPORTABLE.

Description of Event or Problem

ON SEPTEMBER 4, 2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE CPT-3191 FOLDER), FROM ITALY. THE CUSTOMER COMPLAINT FORM REPORTS THAT "PLATE DOESN'T LOCK TO TITANIUM CORE AS IT SHOULD". WE WERE INFORMED ON SEPTEMBER 4, 2024, THAT "THE SURGEON WILL HAVE TO RE OPERATE THE PATIENT, REMOVE THE PAD AND USE A NEW ONE". THEN WE WERE INFORMED ON OCTOBER 11, 2024, THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024.