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

Model Number	58-3200-BD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the incident was not returned.The customer returned a separate device that also had a screw fall out.However, the screw was missing and not returned with the device.Without the screw we cannot determine if the device had the proper laser welding and glue.As a result, the root cause cannot be determined.The device was purchased in may 2021 and has been in use for 1.5 years prior to the problem occurring.Based on the above information no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.
Event or Problem Description
The customer alleged that they had a gold screw fall out of the kerrison and into the patient.The screw was retrieved with no harm to the patient.The customer has had another one fall out with no patient involvement and the screw is lost.

• Brand Name: SYMMETRY
• Common Device Name: KERRISON 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: 16259355
• Report Number: 3007208013-2023-00003
• Device Sequence Number: 11982181
• Product Code: HAE
• UDI-Device Identifier: 00887482102503
• UDI-Public: 00887482102503
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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: 58-3200-BD
• Device Catalogue Number: 58-3200-BD
• Device Lot Number: T01-82005919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown