V.MUELLER

Additional Manufacturer Narrative

THE GERZOG MALLET SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION. EVALUATION RESULTS DETERMINED THAT THE MALLET HAD BEEN MISHANDLED (LIKELY DROPPED). THE STEEL CASING WAS HEAVILY DENTED AND THE LEAD INSERT WAS SEVERELY DEFORMED. THE INSTRUCTIONS FOR USE STATES, "AVOID MECHANICAL SHOCK OR OVERSTRESSING THE DEVICES." "PRIOR TO USE, INSPECT DEVICES TO ENSURE PROPER FUNCTION AND CONDITION. DO NOT USE DEVICES IF THEY DO NOT SATISFACTORILY PERFORM THEIR INTENDED FUNCTION OR IF THEY HAVE PHYSICAL DAMAGE." STERIS PERFORMED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION FOR THE GERZOG MALLET. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

STERIS HAS REQUESTED THE DEVICE SUBJECT OF THE REPORTED EVENT BE SENT BACK FOR EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR GERZOG MALLET BECAME "DENTED" AND METAL "SLIVERS" WERE OBSERVED AROUND THE PATIENT. USER FACILITY PERSONNEL PERFORMED AN X-RAY AND CONFIRMED NO METAL WAS PRESENT IN THE PATIENT. NO REPORT OF INJURY.