IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN OUTPATIENT OPERATION WHEN AN UNIDENTIFIED 6 MM GUIDEWIRE WAS NOTICED INSIDE THE PATIENT. THE GUIDEWIRE WAS REMOVED DURING THE PROCEDURE. THE PATIENT HAD UNDERGONE AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION IN 2007 (APPROXIMATELY 1 YEAR BEFORE) AT A DIFFERENT FACILITY. ARTHREX INC. HAD NOT BEEN NOTIFIED OF ANY EVENTS DURING THIS PERIOD INVOLVING ANY GUIDEWIRES BREAKING AND BEING LEFT IN THE PATIENT. THE REPORTER COULD NOT PROVIDE THE ACTUAL PART NUMBER OF THE GUIDEWIRE RECOVERED FROM THE PATIENT, AND IT CANNOT BE VERIFIED THAT THIS DEVICE WAS IN FACT AN ARTHREX DEVICE FROM THE INFORMATION PROVIDED. THE PART NUMBER REFERENCED IN THIS REPORT WAS USED FOR REPORTING PURPOSES ONLY. NO FURTHER PATIENT INFORMATION IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.
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Patient 1
THE DEVICE WAS NOT RETURNED AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND THE MANUFACTURING DATE WAS NOT DETERMINED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.