ACCULAN 3TI DRILL AND REAMER

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 ACCULAN 3 TI DRILL. IT WAS REPORTED THAT DURING A HIP PROSTHESIS PROCEDURE, WHEN MILLING THE CUP, THE AESCULAP 3 TI MACHINE FAILED AND IT WAS NO LONGER POSSIBLE TO APPLY TORQUE TO THE MACHINE. THEN THE SURGEON HAD TO SPEND A LOT OF TIME AND EFFORT TO GET ANOTHER MACHINE OUT OF THE SURGERY ROOM TOOL, WHICH PLACED ADDITIONAL DEMANDS ON THE STERILIZATION PROCESS. THERE WAS NO HARM TO THE PATIENT, BUT THE SURGERY AND THUS THE TIME OF ANAESTHESIA WAS EXTENDED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

GENERAL INFORMATION: WE DID RECEIVE THE DEVICE FOR AN INVESTIGATION. CONSEQUENCES FOR THE PATIENT SIGNIFICANT SURGERY DELAY. INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE DEVICE WAS SENT IN AS A NORMAL REPAIR, HENCE NO PICTURES HAVE BEEN TAKEN INITIALLY. THE DEVICE WITH THE SERIAL NUMBER#: (B)(6) WAS MANUFACTURED IN JUNE 2012 AND DELIVERED IN AUGUST 2012. SINCE THAT DATE, TWO REPAIRS/MAINTENANCES HAVE TAKEN PLACE (SEPTEMBER AND NOVEMBER 2015). DURING THE INSPECTION, IT WAS DETECTED THAT THERE IS NO FUNCTION. THIS CAN BE TRACED BACK TO A DEFECTIVE STATOR. THE BALL BEARINGS SHOW ABRASION AND WEAR AND TEAR. IN GENERAL WE SUSPECT THAT THE FAILURE IS MOST LIKELY WEAR AND TEAR RELATED. A MAINTENANCE SHOULD BE EXECUTED AT LEAST ONCE PER YEAR ACCORDING TO THE IFU AND THE MARKING ON THE MACHINE. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO FURTHER SIMILAR COMPLAINTS REGISTERED AGAINST THE SAME LOT NUMBER. CONCLUSION AND ROOT CAUSE THE FAILURE IS MOST PROBABLY RELATED TO WEAR AND TEAR (MISSING MAINTENANCE). RATIONALE: REFER TO INVESTIGATION.

Additional Manufacturer Narrative

UPDATED E: REPORTER.