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

Model Number	2841
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The device is not available for evaluation.If the device becomes available as such, a follow-up report will be submitted accordingly.
Additional 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
• Common Device Name: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8245034
• Report Number: 9616086-2019-00004
• Device Sequence Number: 19383857
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K053223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

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: 2841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018; 02/14/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/14/2019; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1