PENCAN®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # EXEMPT.

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: PATIENT IN THE OPERATING ROOM FOR A TOTAL RIGHT KNEE REPLACEMENT UNDER SPINAL ANESTHESIA. THE SPINAL NEEDLE BROKE DURING THE PROCEDURE, AND THE NEEDLE TIP REMAINED LODGED IN THE RIGHT L2 ZYGAPOPHYSEAL JOINT. CT SCAN CONFIRMS: NEEDLE TIP LOCATED IN THE RIGHT L2 JOINT SPACE. PATIENT INFORMATION: CURRENT PATIENT STATUS: CLINICAL MANAGEMENT: NEUROSURGEON CONSULTATION PERFORMED: RECOMMENDATION FOR DELAYED REMOVAL OF THE FRAGMENT, AS THERE IS CURRENTLY NO NEUROLOGICAL DEFICIT OR SPINAL PAIN. THE PATIENT HAS BEEN INFORMED AND WILL BE SCHEDULED FOR A CONSULTATION AND A DELAYED PROCEDURE IN 4 WEEKS. NO LOWER BACK PAIN REPORTED. REMOVAL OF THIS FOREIGN BODY IS INDICATED, THOUGH NOT AS AN EMERGENCY, IN ANTICIPATION OF ANY POTENTIAL FUTURE MRI REQUIREMENTS. THE EXTRACTION PROCEDURE DOES NOT APPEAR TO PRESENT TECHNICAL DIFFICULTIES FOR THE CONSULTING NEUROSURGEON. HOWEVER, IT WILL REQUIRE A SHORT GENERAL ANESTHESIA IN A PRONE POSITION, WHICH CAN BE ORGANIZED AS AN OUTPATIENT PROCEDURE, PRECEDED BY NEW IMAGING UPON ARRIVAL TO ENSURE NO MIGRATION OF THE HARDWARE HAS OCCURRED. IT WAS THEREFORE DECIDED TO PRIORITIZE THE PATIENT'S 3 WEEKS OF REHABILITATION FOLLOWING THE TOTAL KNEE REPLACEMENT. ACTIONS TAKEN WITHIN THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: DELAYED REMOVAL OF THE FOREIGN BODY (APPROXIMATELY 1 MONTH). NO OTHER BATCHES AVAILABLE FOR THIS DEVICE, WHICH IS ALREADY EXPERIENCING SUPPLY SHORTAGES. A NEW ORDER IS IN PROGRESS TO SWITCH THE BATCH.