MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; TRITON DTS PKG US STD

Catalog Number	2841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that unit errored during treatment, the clinician went to remove rope, but it jerked back into the unit pulling the doctors arm and patients head.The device has not been returned for evaluation, complaint could not be confirmed.The rool cause could not be established.If more information becomes available additional reporting on this event will be provided as a supplemental report to this document.
Event or Problem Description
It was reported that unit errored during treatment, the clinician went to remove rope, but it jerked back into the unit pulling the doctors arm and patients head.

• Brand Name: CHATTANOOGA
• Common Device Name: TRITON DTS PKG US STD
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 20627257
• Report Number: 9616086-2024-00098
• Device Sequence Number: 8792375
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K053223
• 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): 11/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2841
• Device Lot Number: T2533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown