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

Catalog Number 55-7003

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

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 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
• Type of Device: GARRETT DILATOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 8696320
• MDR Text Key: 148270749
• Report Number: 3007208013-2019-00019
• Device Sequence Number: 1
• Product Code: DWP
• UDI-Device Identifier: 00887482085240
• UDI-Public: 00887482085240
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1