CRANIAL PERFORATOR 9/12MM HUDSON SHANK

Additional Manufacturer Narrative

REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINT: NETHERLANDS. IT WAS REPORTED THAT THE TREPANE DOESN'T STOP AUTOMATICALLY.

Additional Manufacturer Narrative

INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED OUT BY THE ATS DEPARTMENT. OPTICALLY, DAMAGES AND IMPACT MARKS CAN BE FOUND AT THE OUTER AND INNER CUTTING EDGES OF THE MILL. THE SHAFT OF THE PERFORATOR IS IN GOOD CONDITION AND THE RELEASE FUNCTION IS GIVEN WITH A NEW MILL. IN COMBINATION WITH THE COMPLAINED MILL, HIGH FORCES ARE NECESSARY, THEREFORE A CORRECT RELEASE OF THE PERFORATOR IS NOT POSSIBLE. THE REASON FOR THAT ARE THE DAMAGED CUTTING EDGES. THESE DAMAGES ARE MOST LIKELY ATTRIBUTED TO AN INCORRECT HANDLING OR IMPROPER STORAGE. BATCH HISTORY REVIEW: THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF A MATERIAL DEFECT OR A MANUFACTURING ERROR. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED DUE TO AN INCORRECT HANDLING OR AN INSUFFICIENT MAINTENANCE OF THE DEVICE. NO CAPA IN NECESSARY.