MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-ORTHO TRAUMA CDS

Catalog Number	CDS985210G
Medical Device Problem Codes	Fire (1245); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on 01/27/2025 "at the start of the case" the cautery tip experienced visualized "flame" per the surgeon.
Additional Manufacturer Narrative
According to the facility on 01/27/2025 "at the start of the case" the cautery tip experienced visualized "flame" per the surgeon.Per the facility the cautery tip was clear of debris and the power setting was set to "50/50 then 40/40".Per the facility there was no injury or medical intervention that occurred or was required.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-ORTHO TRAUMA CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21400051
• Report Number: 1423395-2025-00014
• Device Sequence Number: 9576289
• Product Code: OJH
• UDI-Device Identifier: 10195327553319
• UDI-Public: 10195327553319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: CDS985210G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 58 KG