OMBREDANNE MALLET 895GR HEAD-D40MM 240MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - LOT NUMBER D9 - PRODUCT RETURN H3 - YES, EVALUATION H4 - MANUFACTURE DATE H6 - CODES UPDATED INVESTIGATION RESULTS: VISUAL INSPECTION: THE EDGES OF THE MALLET ARE HEAVILY WORN, AND BURRS CAN BE FOUND AT ONE SIDE. 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(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 ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THE COMPLAINED PROBLEM COULD BE CONFIRMED; A LATERAL IMPACT ON THE EDGE OF THE MALLET WILL RESULT IN THE DAMAGE FOUND. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. BASED UPON 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 FL066R - OMBREDANNE MALLET 895GR HEAD-D40MM 240 MM. ACCORDING TO THE COMPLAINT DESCRIPTION, A PART OF THE HEAD BROKE OFF AND HIT ASSISTANT'S EAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SPARE DEVICE. SURGICAL INTERVENTION WAS THEN NECESSARY TO REMOVE THE PIECE. 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. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).