CAST REMOVAL SAW STAINLESS STEEL BLADES

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 THE PATIENT¿S GREAT TOE WAS CUT WHILE REMOVING A CAST USING THE CAST REMOVAL SAW (ID: TCC2SAWSSB). IT WAS STATED THAT THE PRODUCT MALFUNCTIONED, AS IT IS NOT SUPPOSED TO CUT THE SKIN. DUE TO THE INJURY, STITCHES WERE REQUIRED. THE PROCEDURE WAS PERFORMED AND COMPLETED BY A TRAINED REGISTERED NURSE. THE PATIENT HAS ONE CHRONIC WOUND, STAGE 4 KIDNEY DISEASE, AND IS AWAITING A TRANSPLANT.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE CAST REMOVAL SAW WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS IMPROPER PLACEMENT OF THE SKULL CLAMP, RESULTING IN SLIPPAGE. 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.