MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY CUSHING; RONGUER

Model Number	57-2052
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer submitted voluntary report# mw5096744.Symmetry received a copy of this report from the fda on 10/14/2020.Based on the lot number on the device, it was determined that the instrument was purchased in june 2019 and has therefore, been in use for over a year.Upon the initial evaluation of the returned instrument, it was noted that there was significant signs of wear and tear on the entire instrument and it was confirmed that the jaw of the instrument was broken off.The broken piece was returned with the device.Upon evaluation of the jaws, their appeared to be damage that is consistent with biting an object too hard or large for the device.The instrument was tested for hardness and it was confirmed to be within conformance per the product specifications and intended use.This is the first complaint that we have received for the product code of this nature with (b)(4) sold since 2012.This is an isolated event and nothing in our evaluation of the device determined that the damage occurred due to a defect in the manufacturing or material of the device.This damage was likely the cause of excessive stress on the jaws during use.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
The jaw of the pituitary rongeur broke off and fell into the patient.The piece was retrieved with no harm to the patient.

• Brand Name: SYMMETRY CUSHING
• Common Device Name: RONGUER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10775076
• Report Number: 3007208013-2020-00032
• Device Sequence Number: 17166073
• Product Code: HAE
• UDI-Device Identifier: 00887482094679
• UDI-Public: 00887482094679
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K081651
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: 57-2052
• Device Catalogue Number: 57-2052
• Device Lot Number: 120318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1