PROXIMAL REAMER

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT, DURING AN INTRAMEDULLARY NAIL SURGERY, THE SURGEON DRILLED THE DISTAL BONE TO CREATE A NEW MEDULLARY CANAL, SINCE PATIENT REQUIRED MEDULLARY CANAL ACCESS AND FRACTURE REDUCTION, USING A 4.0 MM DRILL BIT; AND AN OLIVE-TIPPED GUIDE WIRE WAS INSERTED. UPON ATTEMPTING TO ADVANCE, THE REAMERS (9.0MM ENDCUTTING IRH, 9.5MM PILOT NOSE IRH, 10.0MM PILOT NOSE IRH,10.5MM PILOT NOSE IRH) FROM ONE (1) TRIGEN REAMER SET AND ONE (1) T HANDLE REAMER 5.0MM, WERE NOT POWERFUL ENOUGH TO PENETRATE THE BONE. ADDITIONALLY, THE ASSIGNED MOTOR OVERHEATED, AND RAN OUT OF USABLE BATTERY POWER. WHILE A LOANER MOTOR WAS BEING PROCURED, ATTEMPTED TO REAM THE PROXIMAL DIAPHYSIS USING A PROXIMAL REAMER, BUT THE INSTRUMENT FRACTURED DURING THE ATTEMPT. A SUBSEQUENT ATTEMPT WAS MADE TO REAM THE DIAPHYSIS USING THE REAMERS (WITH THE LOANER MOTOR), BUT THEY REMAINED INSUFFICIENT TO COMPLETE THE PROCEDURE, AS THEY LACKED ADEQUATE CUTTING SHARPNESS. THE DOCTOR DECIDED TO RESCHEDULE THE SURGERY USING IMPLANTS FROM A DIFFERENT VENDOR. THE SURGERY WAS CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.