MAUDE Adverse Event Report: DJO, LLC TRITON DTS PKG US STD; EQUIPMENT, TRACTION, POWERED

Model Number 2841

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2018

Event Type  malfunction  

Event Description

It was reported that the traction machine "will pull or release rope without any warning".The event reportedly occurred while testing the machine; there was no patient involvement.

Manufacturer Narrative

The device is not available for evaluation.If the device becomes available as such, a follow-up report will be submitted accordingly.

Manufacturer Narrative

The device was returned for evaluation.We could not replicate the rope pulling too hard or feeding out on its own; the safety risk could not be confirmed.The device passed all functional testing but would not return all the way to zero pounds; it went down to 4 pounds.This would not have contributed to the incident or have been a safety risk as it still returned to the range where the rope could release.The motor control circuit board was replaced and the device was calibrated.The spring was replaced because the rope would not retract all the way into the device.This would not have contributed to the event.

• Brand Name: TRITON DTS PKG US STD
• Type of Device: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8245034
• MDR Text Key: 133086440
• Report Number: 9616086-2019-00004
• Device Sequence Number: 1
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• Combination Product (y/n): N
• PMA/PMN Number: K053223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1