MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY DECKER; RONGEUR

Model Number	53-4002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We received user facility report# (b)(4).We have not received any additional information regarding the incident or details about the device.We will continue to reach out to the customer for more information.This the first occurrence for this part number with (b)(4) sold of all lots.A follow up report will be submitted once we have received additional information.
Event or Problem Description
The customer alleged that while using the micro pituitary rongeur, the instrument broke at the tip.
Additional Manufacturer Narrative
After multiple attempts to obtain additional information, no response was received.The lot number/date of purchase is unknown.A picture of the device was not provided, and the device was not returned for evaluation.Without additional information, a true investigation can not take place and a root cause cannot be determined.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.

• Brand Name: SYMMETRY DECKER
• Common Device Name: RONGEUR
• 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: 14794634
• Report Number: 3007208013-2022-00021
• Device Sequence Number: 5074191
• Product Code: HAE
• UDI-Device Identifier: 00887482023457
• UDI-Public: 00887482023457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 53-4002
• Device Catalogue Number: 53-4002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown