inforMED
MalfunctionDWS

TUNNELER AV-1

Received Sep 24, 2020 · Event occurred Jun 30, 2020

Report 3011175548-2020-01164 · MDR key 10584235

Device

Generic name

Instruments, Surgical, Cardiovascular

Model number

26012

Catalog number

26012

Product problems

  • Loose or Intermittent Connection
  • Mechanical Problem
  • Mechanical Problem

Patient

Not reported

  • No Information
  • No Clinical Signs, Symptoms or Conditions
  • No Information
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

CORRECTED SECTION: D.1 & D.4 THE REPORTED COMPLAINT IS IN REGARDS TO THE TUNNEL TIPS NOT BEING ABLE TO BE SCREWED ON TO THE AV-1 TUNNELER ROD. UPON RECEIPT AND INSPECTION OF THE RETURNED TUNNELER ROD IT WAS DETERMINED THAT THE VENDOR WHO SUPPLIES ATRIUM MEDICAL WITH THE TUNNELER ROD HAD NOT TAPPED THE THREADS INTO THE TUNNELER ROD TIP. WITHOUT THREADS THE TIPS WILL NOT FIT ONTO THE TUNNELER. THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED THEREFORE A REVIEW OF THE ACTUAL DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. A SHIP HISTORY WAS PERFORMED ON THE PRODUCT THAT WAS SHIPPED TO THE FACILITY AND THOSE DEVICE HISTORY RECORDS WERE REVIEW AND THE FOUR (4) LOTS OF PRODUCT SHIPPED WERE FOUND TO HAVE MET SPECIFICATIONS. THIS TUNNELER ROD KIT IS A COMBINATION KIT THAT CONTAINS MULTIPLE TUNNELER ROD CONFIGURATIONS AND TUNNELER TIPS. ACCEPTABLE RODS ARE PLACED IN A PACKAGING BASE/BOX; BOX IS THEN CLOSED AND LABELED. NO UNITS WERE REJECTED. A PACKAGING AND LABEL INSPECTION WAS PERFORMED AND NO UNITS WERE REJECTED. THE TUNNELER ROD WAS MANUFACTURED BY OMNI COMPONENTS. LOT WAS RECEIVED AND INSPECTED WHICH INCLUDED A VERIFICATION OF SUPPLIER INSPECTION DIMENSIONS. PER SPECIFICATION THE CRITICAL DIMENSION 4 (DELTA 4) SHOWS THE THREADED AREA ON THE ROD. DELTA 4 REQUIRES 10-24UNC-2B THREADS. THE VENDOR INSPECTS DELTA 4 AT AN AQL 1.0, C=0, USING A GO/NO-GO GAGE. THE INSPECTION RECORD INDICATES 21 PARTS WERE INSPECTED AND PASSED. OMNI COMPONENTS WAS QUALIFIED TO FABRICATE THE GRAFT TUNNELER RODS. THE QUALIFICATION DEMONSTRATED PART CONFORMANCE TO DELTA 4 (10-24 UNC-2B THREAD) AT AN AQL LEVEL FOR THREE LOTS AND AUTHORIZED OMNI COMPONENTS TO PRODUCE THE PART. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: ¿PRIOR TO STERILIZATION, VISUALLY INSPECT INSTRUMENTS FOR DAMAGE. IF THE THREADS OF THE RODS OR TIPS APPEAR DAMAGED OR DO NOT FIT PROPERLY, DO NOT USE.¿ BASED ON THE CONFIRMATION OF THE NONCONFORMING TUNNELER ROD A SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

ON COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

REPORT RECEIVED STATED THAT THE TIP OF THE TUNNELER WAS UNABLE TO SCREW ONTO THE TUNNELER.