CHATTANOOGA 2841Recalls & reported problems
Djo, LLC · TRITON DTS PKG US STD · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912022170), received between Jan 14, 2019 and Nov 7, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Key or Button Unresponsive/not Working1
- Mechanical Problem1
- Retraction Problem1
- Unintended System Motion1
Patient problems
- No Patient Involvement2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UNIT ERRORED DURING TREATMENT, THE CLINICIAN WENT TO REMOVE ROPE, BUT IT JERKED BACK INTO THE UNIT PULLING THE DOCTORS ARM AND PATIENTS HEAD.
Patient problems: Insufficient Information
MAUDE report 20627257 ↗MalfunctionApr 16, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
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."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122354 ↗MalfunctionMar 5, 2019Retraction Problem; Retraction Problem
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.
Patient problems: No Patient Involvement
MAUDE report 8389946 ↗MalfunctionJan 30, 2019Unintended System Motion; Unintended System Motion
IT WAS REPORTED THAT THE TRACTION DEVICE POWERED OFF AND TURNED ON AGAIN DURING TREATMENT. IT THEN SUDDENLY PULLED ON THE PATIENT'S NECK. THERE WAS REPORTEDLY NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8288448 ↗MalfunctionJan 14, 2019Mechanical Problem; Mechanical Problem
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.
Patient problems: No Patient Involvement
MAUDE report 8245034 ↗
Other EQUIPMENT, TRACTION, POWERED devices
- Decompression of Choice E9011Pivotal Health Solutions, Inc. · Equipment, Traction, Powered1 report
- CHATTANOOGA 8250Djo, LLC · EQUIPMENT, TRACTION, POWERED1 report
- Modpod 12.1000Hollywog, LLC · Equipment, Traction, Powered1 report
- CHATTANOOGA 4759Djo, LLC · EQUIPMENT, TRACTION, POWERED1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.