MICRO HOOK BLUNT230MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B1 & B2 - ADVERSE EVENT ADDED. B5 - DESCRIPTION UPDATED. B6 - LAB TEST.

Description of Event or Problem

UPDATE: AN X-RAY WAS REQUIRED. TIP IS OUTSIDE THE NERVE CANAL AND WILL SCAR. NO NEUROLOGICAL DEFICITS. EXPLORATION WAS OFFERED, BUT THE PATIENT DECLINED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON -ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FD333R - VASCULAR SPATULA230MM. ACCORDING TO THE COMPLAINT DESCRIPTION, A PIECE OF THE INSTRUMENT BROKE "OUTSIDE THE CERVICAL SPINE" AND REMAINED IN THE PATIENT. ACCORDING TO THE CUSTOMER, HOWEVER, THERE WAS NO RISK TO THE PATIENT. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. 400707230.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - BATCH NUMBER, D9 - RECEIPT DATE, H3 - YES, EVALUATION, H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS PROVIDED, AND, THEREFORE, WAS AVAILABLE FOR INVESTIGATION. THE PRODUCT WAS RECEIVED IN A USED CONDITION WITH THE WORKING END BROKEN OFF. VISUAL INSPECTION: THE WORKING END IS BROKEN OFF. THE BROKEN OFF PIECE IS NOT AVAILABLE FOR EXAMINATION. THE FRACTURE SURFACE DOES NOT SHOW ANY ABNORMALITIES SUCH AS INCLUSIONS, PORES OR THE LIKE. DURING THE INVESTIGATION, A COMPARISON WAS MADE BETWEEN THE RESULTS OF THE VISUAL EXAMINATION AND THE TECHNICAL DRAWING VALID AT THE TIME OF PRODUCTION. NO DEVIATIONS WERE IDENTIFIED. A REVIEW OF THE CHANGE HISTORY CONFIRMED THAT THERE HAVE BEEN NO MODIFICATIONS IN THE DESIGN, MATERIAL AND MANUFACTURING PROCESSES WITHIN THE LAST FIVE (5) YEARS. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THE CUSTOMER COMPLAINT CAN BE CONFIRMED. THERE IS NO INDICATION FOR A MATERIAL, MANUFACTURING OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

UPDATE: THE LEADING MATERIAL WAS UPDATED TO FD331R - MICRO HOOK BLUNT230MM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. D1 & 2 - BRAND NAME, PRODUCT CODE. D4 - LEADING MATERIAL, BATCH NUMBER. H4 - MANUFACTURE DATE.