DONJOY
Received Apr 22, 2025 · Event occurred Apr 2, 2025
Report 9616086-2025-00045 · MDR key 21886958
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
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BRACE IS HAVING ISSUES WITH THE RIGHT SIDE HINGE. WHEN THEY ENGAGE THE LOCK SWITCH, THE HINGE DOES NOT LOCK. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE BRACE IS HAVING ISSUES WITH THE RIGHT SIDE HINGE. WHEN THEY ENGAGE THE LOCK SWITCH, THE HINGE DOES NOT LOCK.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT SECTION A1.