CCR BLADEFENESTRATED TI BLUNT 45X24MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - BATCH, EXPIRATION DATE. D6 - DEVICE RECEIVED. H3 - YES, EVALUATION. H6 - CODES UPDATED. INVESTIGATION RESULTS: VISUAL INSPECTION: AS A FIRST STEP, A VISUAL INSPECTION OF THE RECEIVED INSTRUMENT AND THE DETACHED PIN WAS CONDUCTED. APART FROM SIGNS OF USE, THERE WERE NO DAMAGE OR DEFECTS FOUND THAT MIGHT INDICATE IMPROPER USE. AFTER THAT, THE DIAMETER OF THE PIN WAS MEASURED WITH A MICROMETER. THE MEASURED DIAMETER OF 2,003 MM IS 0.003 MILLIMETERS ABOVE THE TOLERANCE LIMIT, CAUSED BY THE SURFACE BEING ROUGHENED BY SCRATCHES (DIAMETER SPEC: 2,0MM -0,025). AN UPWARD DEVIATION FROM THE TOLERANCE LIMIT CANNOT BE THE CAUSE OF THE CURRENT PROBLEM (THE PIN FALLING OUT OF THE HOLE). IN THE NEXT STEP THE BORE IN THE INSTRUMENT WAS EXAMINED AND MEASURED WITH A SET OF TEST PINS. IT WAS DETERMINED THAT THE BORE WAS ALSO WITHIN THE TOLERANCE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING 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 AND THE ENTIRE PRODUCT RANGE. 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 REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THE COMPLAINED PROBLEM COULD BE CONFIRMED. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT BW164T - CCR BLADEFENESTRATED TI BLUNT 45X24MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PIN OF THE BALL SNAP THAT CONNECTS TO THE RETRACTOR WAS DETACHED AND MISSING. 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 REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON ANALYSIS OF PICTURE AND EVENT DESCRIPTION. HERE IT WAS FOUND THAT THE PIN WAS MISSING IN THE RIGHT SIDE OF THE INSTRUMENT. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. ALSO AFTER MEANINGFUL ATTEMPTS NO FURTHER INFORMATION COULD BE RECEIVED. 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 REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THE COMPLAINED PROBLEM COULD BE CONFIRMED. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.