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

Model Number	2841
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no indication that the device will be returned to the manufacturer for evaluation.If the device is returned, the device will be evaluated and a follow-up report will be submitted.
Event or Problem Description
It was reported that the traction device was experiencing inconsistent rope recoil.The rope starts making a clicking sound and stops working.There is no indication that there was any patient involvement or patient harm.
Additional Manufacturer Narrative
One triton dts pkg us std (part number 2841 / serial number (b)(4)/ lot number 1018) was returned for evaluation.The unit was tested and found to be working properly.The complaint reported by the customer could not be duplicated.The device history record (dhr) was reviewed.There was no information in the dhr that would indicate a problem that contributed to the reported complaint.Trending data was reviewed and no trend was identified that would indicate a systemic problem.No further action is warranted.

• 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: 8389946
• Report Number: 9616086-2019-00010
• Device Sequence Number: 19190597
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: Lay User/Patient
• Device Model Number: 2841
• Device Lot Number: 1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1