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

Model Number	2841
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "warraty repair, error 208 and 309, the max load was set to 40# and it continued to pull to 60#, the rope release would not release patient at end of the traction treatment even after hitting emergency button, no injury reported.".
Additional Manufacturer Narrative
It was reported that "warraty repair, error 208 and 309, the max load was set to 40# and it continued to pull to 60#, the rope release would not release patient at end of the traction treatment even after hitting emergency button, no injury reported." the device was returned and evaluated.The unit needed a new solenoid.Solenoid replaced, touchscreen back cover replaced and the ribbon cable that connects to the main pcb board.The clamp foot was bent, so it was also replaced.Sent a new patient switch as the other one was no longer functioning.The calibration was set extremely high, the unit was recalibrated and a burn in was performed for 8 hours.No issues or defects were discovered during this process.

• Brand Name: TRITON DTS PKG US STD
• Common Device Name: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 19122354
• Report Number: 9616086-2024-00025
• Device Sequence Number: 7722368
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: 2841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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