IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

DURING T2 HUMERAL SURGERY, THE SURGEON USED BIXCUT IM REAMER. WHEN THE SURGEON USED IM REAMER OF 7.5 MM AND 8.0 MM, THE SHAFT BROKE. THEREFORE THE SURGEON USED ANOTHER SIZE IM REAMER(6.0MM, 6.5MM, 7.0MM, 8.5MM, 9.0MM).

Additional Manufacturer Narrative

THE EVALUATION REVEALED BOTH IM REAMERS TO BE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE REAMERS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE VISUAL, DIMENSIONAL AND MATERIAL INSPECTION REVEALED THAT THE DIMENSIONS AND MATERIAL ARE WITHIN SPECIFICATION AND BOTH REAMERS BROKE DUE TO AN TORSIONAL OVERLOAD; THE REAMER WITH CATALOG NUMBER 02276080 WAS OVERLOADED DURING ROTATION IN COUNTER-CLOCKWISE DIRECTION (THE SPIRAL IS COMPLETELY UNCOILED) AND THE REAMER WITH CATALOG NUMBER 02276075 WAS OVERLOADED DURING ROTATION IN CLOCKWISE DIRECTION. FURTHERMORE THE SPIRAL OF THE REAMER WITH CATALOG NUMBER 02276080 WAS DEFORMED TO APPROX. 110°. THIS DEFORMATION WAS ONLY POSSIBLE DURING USAGE WITHOUT A GUIDE WIRE; OTHERWISE THE GUIDE WIRE WOULD HAVE PREVENTED THE DEFORMATION LIKE PRESENTED. ADDITIONALLY SEVERAL HITTING MARKS WERE FOUND ON THE CUTTING EDGES, INDICATING THAT THE REAMERS HIT METAL DURING THE SURGERY OR DURING PREVIOUS SURGERIES. THE REASON FOR THE TORSION OVERLOADS COULD NOT BE DETERMINED BUT MOST LIKELY THE REAMER BIXCUT HEADS GOT STUCK IN THE MARROW CHANNEL DURING REAMING. IT IS POSSIBLE THAT THE CUSTOMER TRIED TO OPEN THE MARROW CHANNEL STARTING WITH THE Ø7.5 MM REAMER AND THEN WITH THE Ø8.0 MM REAMER. DUE TO A TOO THIN CHANNEL THE REAMERS GOT JAMMED. THE OPERATIVE TECHNIQUE INCLUDES THAT REAMING SHOULD BE DONE IN 0.5MM INCREMENTS UNTIL CORTICAL CONTACT IS APPRECIATED. THE IFU INCLUDES FURTHER THAT REAMING METAL, DRILLING IN COUNTER-CLOCKWISE DIRECTION AND DRILLING WITHOUT A GUIDE WIRE IS NOT ALLOWED. REAMING SHALL BE DONE CAREFULLY AND ONLY SHARP REAMERS SHALL BE USED. THE REAMER BREAKAGES ARE THE RESULT OF A MISUSE AND SEVERAL DEVIATIONS FROM THE IFU AND OPERATIVE TECHNIQUE. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY DISCREPANCIES. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT(S). NO NON-CONFORMITY WAS IDENTIFIED.

Description of Event or Problem

DURING T2 HUMERAL SURGERY, THE SURGEON USED BIXCUT IM REAMER. WHEN THE SURGEON USED IM REAMER OF 7.5 MM AND 8.0 MM, THE SHAFT BROKE. THEREFORE THE SURGEON USED ANOTHER SIZE IM REAMER(6.0MM, 6.5MM, 7.0MM, 8.5MM, 9.0MM).