MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION TUNNELER AV-1; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	26012
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow-up report will be submitted.
Event or Problem Description
Report received stated that the tip of the tunneler was unable to screw onto the tunneler.
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.
Event or Problem Description
N/a.

• Brand Name: TUNNELER AV-1
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10584235
• Report Number: 3011175548-2020-01164
• Device Sequence Number: 10855742
• Product Code: DWS
• UDI-Device Identifier: 00650862260182
• UDI-Public: 00650862260182
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26012
• Device Catalogue Number: 26012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 07/19/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/05/2020; 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1