ACCULAN 3TI DERMATOME

Description of Event or Problem

IT WAS REPORTED TO AESCULAP AG THAT AN ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS USED TO CUT A GRAFT. REPORTEDLY, THE GRAFT WAS COMPLETE, BUT UNEVEN; THE THICKNESS OF THE GRAFT WAS VARYING, WHICH WAS ABNORMAL. AN ADDITIONAL GRAFT NEEDED TO BE TAKEN TO CONTINUE AND COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: VISUAL INVESTIGATION: OPTICALLY, THE DEVICE IS IN A BAD /STRONGLY SOILED CONDITION. THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE COMPLETE RESULTS CAN BE FOUND WITHIN PC NOTIFICATION (B)(4). ACCORDING TO OUR DATABASE, THE PRODUCT WAS MANUFACTURED IN JULY 2012 AND DISTRIBUTED IN AUGUST 2012. THE ONLY REGISTERED REPAIR/MAINTENANCE TOOK PLACE IN NOVEMBER 2021. DUE TO THE BAD CONDITION OF THE DEVICE, A FUNCTIONAL TEST WAS NOT POSSIBLE. IT IS POSSIBLE THAT THE REPORTED FAILURE OCCURRED DUE TO THE BAD OVERALL CONDITION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 2(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.