MAUDE Adverse Event Report: DJO LLC CHATTANOOGA TX TRACTION UNIT PKG; EQUIPMENT, TRACTION, POWERED

Model Number	4759
Medical Device Problem Codes	Unintended Movement (3026); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not indicate that the device will be returned for evaluation.If the device becomes available as such, a follow-up report will be completed upon completion of the evaluation.
Event or Problem Description
It was reported that "it is having an intermittent issue.When the unit has been sitting idle with the rope out and they go to remove all of the slack once attached to the patient, they press the rope release and it violently snaps back with force and a loud noise.Then the rope release will operate normally again in and out until it has been sitting idle again for some time." there was no reported patient harm.
Additional Manufacturer Narrative
Product not returned for inspection and complaint could not be confirmed if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: CHATTANOOGA TX TRACTION UNIT PKG
• Common Device Name: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010 9663
• 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: 8562142
• Report Number: 9616086-2019-00020
• Device Sequence Number: 1836230
• Product Code: ITH
• UDI-Device Identifier: 00888912023825
• UDI-Public: 00888912023825
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: 4759
• 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: 04/03/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown