MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY GARRETT; GARRETT DILATOR

Catalog Number	55-7003
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated upon receiving the device.It was confirmed that the tip of the dilator had broken off of the device.This is a very small instrument with a malleable shaft; if all of the force is placed on the tip of the instrument while bending damage to the weld could occur.A sampling of each lot in inventory were reviewed for any indication that the weld holding the tip was not strong enough.All instruments had secure intact welds with no indication of a non-conformance.There has been a total of (b)(4) sold of this product since 2012 with no additional complaints recorded for this device.This can be seen as an isolated event.Based on the information provided, this can be seen as the final report.If additional information is obtained that alleges additional patient involvement or the need for any additional corrective actions, a follow-up report will be submitted.
Event or Problem Description
During a procedure, the tip of the dilator broke off while it was being bent into shape for use.There was no harm to the patient.

• Brand Name: SYMMETRY GARRETT
• Common Device Name: GARRETT DILATOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8696320
• Report Number: 3007208013-2019-00019
• Device Sequence Number: 14042106
• Product Code: DWP
• UDI-Device Identifier: 00887482085240
• UDI-Public: 00887482085240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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 Catalogue Number: 55-7003
• Device Lot Number: 1811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1