MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS ACCESSORIES TUNNELERS; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	26026
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
On receipt of product it was noted that the #6 and #8 bullet tips were missing.
Additional Manufacturer Narrative
Analysis: as the device in question was not returned atrium medical corporation cannot confirm that there were any tunneler rod tips missing from the tunneler rod kit.There was also no lot number provided with the complaint.If the lot number had been provided the device history records would have been reviewed to ensure that the correct amount of tips was issued to the manufacturing work order prior to manufacturing.The records would also have been reviewed to ensure all parts were used and not scrapped during the process of manufacture.Due to the lot number not being supplied a tunneler rod kit of the same p/n 26026 was obtained from inventory to ensure all tips were accounted for.The review of the materials indicated that all components were accounted for.Conclusion: as the product was not returned and the product lot number in question not provided atrium medical corporation cannot confirm that there were tips missing from the supplied kit to the institution.There has been no other reported complaint regarding missing tunneler tips.H3 other text : product not returned.

• Brand Name: GRAFTS ACCESSORIES TUNNELERS
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9437437
• Report Number: 3011175548-2019-01218
• Device Sequence Number: 14070815
• Product Code: DWS
• UDI-Device Identifier: 00650862260267
• UDI-Public: 00650862260267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: D120332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 26026
• Device Catalogue Number: 26026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other