DONJOY
Received Dec 19, 2024 · Event occurred Nov 27, 2024
Report 9616086-2024-00123 · MDR key 20984402
Device
Generic name
X-rom Post-op Knee Brace
Manufacturer
Djo LlcCatalog number
11-2181-9
Lot number
TJ31726240214
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 CLIP IS BROKEN.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE RED CLIP IS BROKEN. 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.