MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY CLASSIC PLUS; METZENBAUM SCISSOR

Catalog Number	36-5016
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility submitted a voluntary med watch report.Report# mw5093118.This product code has never been purchased by the reporting customer since the acquisition of the codman product line.The customer provided pictures of the damaged product.It could be determined from the pictures that the instrument was sold prior to the actuation.Additionally, the device appeared to have signs of extensive use and appeared to be significantly aged from the appearance of the etching.It can be determined from this information that the instrument became damaged due to wear and tear over years of use.There has been a total of (b)(4) sold of all lots since 2012 with one additional complaint recorded.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.
Event or Problem Description
One blade of the metzenbaum scissor snapped off the handle and fell into the incision site.The blade was retrieved with no harm to the patient.

• Brand Name: SYMMETRY CLASSIC PLUS
• Common Device Name: METZENBAUM SCISSOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch, tn
• MDR Report Key: 9976901
• Report Number: 3007208013-2020-00010
• Device Sequence Number: 17264112
• Product Code: LRW
• UDI-Device Identifier: 00887482010143
• UDI-Public: 00887482010143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 36-5016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1