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

Model Number 4759

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2019

Event Type  malfunction  

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 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.

• Brand Name: CHATTANOOGA TX TRACTION UNIT PKG
• Type of Device: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8562142
• MDR Text Key: 145630069
• Report Number: 9616086-2019-00020
• Device Sequence Number: 1
• Product Code: ITH
• UDI-Device Identifier: 00888912023825
• UDI-Public: 00888912023825
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4759
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1