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

Model Number	58-3230-BD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that during an anterior cervical discectomy and fusion the 9in kerrison fell apart.There was no harm to the patient.
Additional Manufacturer Narrative
The customer informed us that the device is not available for return, the lot number is unknown, and it is unknown when it was purchased.Without pictures of the device, the device itself, or a lot number an investigation cannot be thoroughly completed.Based on the information provided, no further actions is required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or information pertinent to the investigation, a follow up report will be submitted.User facility report received report# 0100230000-2022-8004.

• 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: 15666410
• Report Number: 3007208013-2022-00041
• Device Sequence Number: 19523476
• Product Code: HAE
• UDI-Device Identifier: 00887482088517
• UDI-Public: 00887482088517
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 58-3230-BD
• Device Catalogue Number: 58-3230-BD
• 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: 09/29/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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