PENCIL,45 ABC,FT/S,DISP/10

Additional Manufacturer Narrative

TWO SAMPLES WERE RECEIVED IN UNOPENED, ORIGINAL PACKAGING. THE REPORTED CATALOG AND LOT NUMBERS WERE VERIFIED. VISUAL INSPECTION OF THE DEVICES PACKAGING FOUND A TEAR IN THE POLY SIDE OF THE PACKAGING. MAGNIFICATION OF THE TEAR AREA SHOWS THAT THE TEAR SEEMS TO BE A FINE CUT AND DOES NOT SHOW STRESSING FROM THE DEVICE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 3 COMPLAINTS, REGARDING 7 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CONTRAINDICATIONS: - THESE DEVICES SHOULD NEVER BE USED WHEN: - THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICE, SUCH AS CRACKS, CUTS, PUNCTURES, NICKS, ABRASIONS, DISCOLORATION OR CONNECTOR DAMAGE INSPECTION: - THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF FOUND: - CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; - BROKEN OR SIGNIFICANTLY BENT HANDLE, SHAFT OR CONNECTOR CONTACTS THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR IN (B)(6) REPORTED A "TEAR" ON THE STERILE POUCH OF DEVICE. THIS WOULD BE AN OBVIOUS DEFECT TO THE USER AND WAS THEREFORE NOT DEEMED A REPORTED DEVICE FAILURE. HOWEVER, THE COMPLAINT DEVICE WAS RETURNED TO CONMED FOR EVALUATION AND A HOLE WAS FOUND IN THE PACKAGING THAT WAS LIKELY NOT CAUSED BY THE DEVICE. NO PATIENT INVOLVEMENT AS THIS DEFECT WAS FOUND DURING INCOMING INSPECTION. THIS INCIDENT WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.