MalfunctionITQ
DONJOY
Received Apr 4, 2025 · Event occurred Mar 25, 2025
Report 9616086-2025-00040 · MDR key 21780959
Device
Product problems
- Mechanical Problem
- Unintended System Motion
- No Apparent Adverse Event
- Mechanical Problem
- Unintended System Motion
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RED BUTTON IS NOT HOLDING THE HINGE.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE RED BUTTON IS NOT HOLDING THE HINGE. THE BRACE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT IS DAMAGED COMPONENT BASED ON OTHER DEVICES THAT HAVE BEEN EVALUATED. THE DEVICES LOCK BUTTON FAILED DURING MANUFACTURING TESTING CONFIRMED TO BE THE SAME MALFUNCTION FOUND IN REPORT NUMBER: 9616086-2023-00007. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.