CAST REMOVAL SAW

Additional Manufacturer Narrative

UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE CAST REMOVAL SAW (ID: TCC2SAW) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A FACILITY REPORTED THAT THEIR CAST REMOVAL SAW (ID: TCC2SAW) MALFUNCTIONED DURING USE. THE BLADE STOPPED AGITATING AND THE DEVICE BEGAN PRODUCING A LOUD GRINDING NOISE. THE SAW ALSO BECAME NOTICEABLY HOTTER THAN NORMAL. THE FACILITY IMMEDIATELY DISCONTINUED USE OF THE DEVICE. THE AFFECTED SAW HAD BEEN IN SERVICE FOR APPROXIMATELY SIX YEARS AND WAS IN ACTIVE USE AT THE TIME THE ISSUE OCCURRED. NO PATIENT INJURY.