TREPANBOGEN HUDSON

Additional Manufacturer Narrative

INVESTIGATION RESULTS: VISUALLY, NO DEVIATION COULD BE FOUND AT THE PROVIDED DEVICE. INVESTIGATION WAS CARRIED OUT BY THE Q-COORDINATOR OF THE PRODUCTION PLANT IN CHARGE. EXCERPT OF THE INVESTIGATION REPORT: WHEN CHECKING ITEM FF056R, THE TOLERANCE 0.15 MM (ON BOTH SIDES) ON THE CRANK HANDLE WAS CHECKED WITH A FEELER GAUGE. IF THE CRANK HANDLE IS PRESSED ON ONE SIDE, 0.15 MM OF FEELER GAUGE GOES STRAIGHT INTO THE GAP THAT IS PRESENT FOR THE PLAY. CONVERSELY, THIS MEANS THAT THE SPECIFICATION HAS BEEN MET. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS ONE SIMILAR COMPLAINT AGAINST THE SAME LOT NUMBER(S); SIMILAR COMPLAINT FROM SAME CUSTOMER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 4(5) X PROBABILITY OF OCCURRENCE 1(5) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: BASED ON THE INVESTIGATION REPORT OF THE RESPONSIBLE Q-COORDINATOR, THE PRODUCT IS ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DETERMINED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED TO AESCULAP AG THAT A TREPANBOGEN HUDSON (PART # FF056R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GLOVE WAS CAUGHT IN THE GAP OF THE DEVICE HANDLE AND SUBSEQUENTLY TORE. REPORTEDLY, THE GLOVE TORE TWICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).