ESTEEM+

Description of Event or Problem

TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. ROOT CAUSE ANALYSIS. ERROR CATEGORY: EMPLOYEE. FINDINGS: ¿ EQUIPMENT WAS CAPABLE, WITHIN VALIDATED PARAMETERS. ¿ NO EQUIPMENT MALFUNCTION IDENTIFIED. ¿ PERSONNEL WERE TRAINED AND QUALIFIED. ¿ ROOT CAUSE: VISUAL INSPECTION WAS NOT PROPERLY PERFORMED, ALLOWING OFF CENTER HOLES TO PASS UNDETECTED. IMMEDIATE ACTIONS. ¿ REVIEW OF IN PROCESS AND FINISHED GOODS FOR HOLE CENTRICITY. ¿ AFFECTED LOTS WERE ALREADY PROCESSED, SO NO PHYSICAL CONTAINMENT POSSIBLE. ¿ ACTIONS FOCUSED ON: O PROCESS REVIEW. O OPERATOR RE SENSITIZATION. O STRENGTHENING INSPECTION CONTROLS. ¿ QA AND PRODUCTION WERE NOTIFIED. ¿ IMPLEMENTED: (B)(6) 2026. CORRECTIVE ACTIONS (CA). ¿ REINFORCEMENT OF OPERATOR RESPONSIBILITIES FOR VISUAL INSPECTION. ¿ RE SENSITIZATION OF OPERATORS ON HOLE CENTRICITY ACCEPTANCE CRITERIA. ¿ IMPLEMENTED: (B)(6) 2026. PREVENTIVE ACTIONS (PA). ¿ INTRODUCTION OF GO/NO GO INSPECTION TEMPLATES FOR OBJECTIVE HOLE CENTRICITY CHECKS. ¿ REVISION OF WORK INSTRUCTIONS (WI), INCLUDING MANDATORY USE OF TEMPLATES. ¿ INTEGRATION OF TEMPLATES INTO ROUTINE PROCESS CONTROLS TO REDUCE RELIANCE ON SUBJECTIVE INSPECTION. ¿ IMPLEMENTATION DATE: (B)(6) 2026. ¿ RESPONSIBLE: ENGINEERING & QUALITY ASSURANCE (QA). CAPA DECISION. NO FORMAL CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REQUIRED. JUSTIFICATION: ¿ ISOLATED OPERATOR ERROR, NOT A SYSTEMIC FAILURE. ¿ IMPLEMENTED CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DEEMED SUFFICIENT. ¿ CONTINUED MONITORING VIA QUALITY TREND ANALYSIS. EFFECTIVENESS VERIFICATION. SCHEDULED ACTIVITIES INCLUDE: ¿ CONFIRMING TEMPLATE AVAILABILITY AND USAGE. ¿ POST IMPLEMENTATION SAMPLING TO VERIFY HOLE CENTRICITY. ¿ MONITORING FOR RECURRENCE. REVIEW DATE: (B)(6) 2026. ADDITIONAL REMARKS. PREVENTIVE ACTIONS INTRODUCE OBJECTIVE, RISK-BASED INSPECTION METHODS, REDUCING DEPENDENCY ON HUMAN JUDGEMENT AND STRENGTHENING PROCESS CONTROL. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 1049092. THIRD PARTY MANUFACTURING SITE (FOR LIFE): 3003759552.

Description of Event or Problem

THE END USER REPORTED THAT TWO WAFERS HAD STARTER HOLES THAT WERE POSITIONED OFF-CENTER. THE PRODUCT WAS NOT USED BY PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

Additional Manufacturer Narrative

DEVICE 1 OF 2. E1: COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: JAPAN. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, THIRD PARTY MANUFACTURING SITE (FOR LIFE): 3003759552.