DONJOY
Received Dec 19, 2024
Report 9616086-2024-00129 · MDR key 20984397
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 BRACE WILL NOT REMAIN LOCKED ANYMORE AND WILL COME UNDONE WITH LITTLE FORCE AFTER A SHORT TIME OF USE. I WOULD ASSUME THIS IS A PROBLEM WITH THE BUTTON/ MECHANICS OF THE HINGE. NO INJURY CAUSED.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BRACE WILL NOT REMAIN LOCKED ANYMORE AND WILL COME UNDONE WITH LITTLE FORCE AFTER A SHORT TIME OF USE. I WOULD ASSUME THIS IS A PROBLEM WITH THE BUTTON/ MECHANICS OF THE HINGE. NO INJURY CAUSED. 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.