IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM

Additional Manufacturer Narrative

PLEASE REFER TO D9 - THE PRODUCT WAS RETURNED FOR INVESTIGATION, H6 COMPONENT AND METHOD CODES. THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED AND MATCHES THE ALLEGED FAILURE. THE PROVIDED IM REAMER SHAFT OF THE BIXCUT SYSTEM SHOWS EXTENSIVE SIGNS OF USAGE. THE REAMER SHAFT IS BROKEN AT THE LAST WINDINGS NEAR THE REAMER HEAD (DISTAL PORTION). THE BREAKAGE SURFACES SHOW THE TYPICALLY ROUGH AND CLIFFY STRUCTURE OF A DUCTILE OVERLOAD FRACTURE. THE BREAKAGE PATTERN INDICATES TORSIONAL OVERLOADING UNDER A STUCK STATE AND MOST LIKELY DUE TO WHICH THE REAMER COULDN¿T PROCEED FURTHER RESULTING IN TORSIONAL OVERLOAD AND BREAKAGE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED. BASED ON THE INVESTIGATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO USER-RELATED AS HIGH TORSIONAL OVERLOAD LED TO THE BREAKAGE. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

AS REPORTED: "DURING PROCEDURE, THE REAMER WAS BROKEN." ADDITIONAL INFORMATION: ALL DEBRIS WERE REMOVED FROM THE PATIENT. THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

AS REPORTED: "DURING PROCEDURE, THE REAMER WAS BROKEN".