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 devices have been in use for approximately a year.This customer has experienced multiple occurrences of screws falling out of the devices this year.While a true root cause cannot be determined, there is most likely a problem within the facility.We are working with the sales representative and the facility to solve the problem the returned devices had a small amount of damage on the screw heads that was inconclusive to the screws being tampered with.We are continue to track and trend the occurrence with the above informaiton, no further actions are required.This can be seen as the final report.If additional patient involvement information is provided, or additional information pertinent to the investigation, a follow up report will be submitted.
Event or Problem Description
The custoemr alleged that the screw fell out of the two kerrisons during the same procedure.

• 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: 16259354
• Report Number: 3007208013-2023-00004
• Device Sequence Number: 14672753
• Product Code: HAE
• UDI-Device Identifier: 00887482102503
• UDI-Public: 00887482102503
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Remedial Action: Repair
• 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: T01-82104425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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