V. MUELLER

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION; HOWEVER, PHOTOGRAPHS OF THE DEVICE WERE PROVIDED BY THE USER FACILITY FOR INVESTIGATION PURPOSES. UPON FOLLOW-UP WITH USER FACILITY PERSONNEL AND REVIEW OF THE PHOTOGRAPHS IT WAS OBSERVED THAT THE DEVICE HAD THREAD DAMAGE INDICATIVE OF EXCESSIVE FORCE DURING USE. THE T-1295 SHADOW-LINE SIDE LOADING LOCKING RETRACTOR BLADE HANDLE INSTRUCTIONS FOR USE STATES, "AVOID MECHANICAL SHOCK OR OVERSTRESSING THE DEVICES." THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A STERIS ACCOUNT MANAGER OFFERED IN-SERVICE TO THE USER FACILITY ON THE PROPER USE AND OPERATION OF THE T-1295 SHADOW-LINE SIDE LOADING LOCKING RETRACTOR BLADE HANDLE AND IS PENDING A RESPONSE.

Additional Manufacturer Narrative

A STERIS ACCOUNT MANAGER COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE T-1295 SHADOW-LINE SIDE LOADING LOCKING RETRACTOR BLADE HANDLE, SPECIFICALLY THE IMPORTANCE OF AVOIDING MECHANICAL SHOCK OR OVERSTRESSING THE DEVICE DURING USE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A SCREW TO THEIR SHADOW-LINE SIDE LOADING LOCKING RETRACTOR BLADE HANDLE WOULD NOT FULLY LOOSEN TO ALLOW THE RETRACTOR BLADE TO ATTACH. A PROCEDURE DELAY WAS REPORTED AS ANOTHER RETRACTOR BLADE HAD TO BE UTILIZED TO COMPLETE THE PROCEDURE. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE