SYMMETRY ELEVATOR, FREER SEPTUM, 4.5MM TIP WIDTH

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION. PICTURES WERE ALSO PROVIDED, HOWEVER THE LOT NUMBER WAS NOT PROVIDED. AFTER EXAMINING THE SAMPLE, IT WAS CONFIRMED TO BE BROKEN. ALTHOUGH NO LOT NUMBER WAS PROVIDED, BASED ON THE ETCH OF "CODMAN" ON THE INSTRUMENT IT IS KNOWN THAT THE DEVICE IS AT LEAST 12 YEARS OLD. IT IS UNCLEAR IF THIS PRODUCT WAS BEING USED ACCORDING TO THE INTENDED USE. THIS IS CONSIDERED NORMAL WEAR AND TEAR AND AN ISOLATED INCIDENT. ROOT CAUSE WAS NORMAL WEAR AND TEAR, AND THE DEVICE REACHING THE END OF ITS USEFUL LIFE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

THE ACTUAL DEVICE IS AVAILABLE FOR EVALUATION, AND IS IN PROCESS OF BEING RETURNED. THE MODEL NUMBER WAS PROVIDED, BUT THE LOT NUMBER IS CURRENTLY UNKNOWN. THE INVESTIGATION IS ONGOING. ONCE WE HAVE COMPLETED THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION. NOTE THAT THIS COMPLAINT WAS RECEIVED VIA MEDWATCH MW5161716.

Description of Event or Problem

COMPLAINANT ALLEGES "FREER ELEVATOR BROKE WHILE IN USE. ALL PIECES WERE ABLE TO BE RETRIEVED BY SURGEON. FREER WAS REMOVED FROM FIELD AND REPLACED. NO HARM TO PATIENT." THIS WAS RECEIVED VIA MW5161716.