FINGER JOINT IMPLANT W/ GROMMETS 6
Received May 19, 2025 · Event occurred Apr 22, 2025
Report 3010667733-2025-00599 · MDR key 22046828
Device
Generic name
Prosthesis, Finger, Polymer
Manufacturer
Wright Medical Technology IncCatalog number
G4700006
Lot number
1767175
Product problems
- Break
- Fracture
- Material Deformation
- Break
- Fracture
- Material Deformation
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE FINGER JOINT THAT APPEARED TO BE DAMAGED ON THE DISTAL END OF THE PROSTHESIS. THE OPERATION WAS TO REMOVE THE IMPLANT THAT WAS IMPLANTED 2 MONTHS AGO AND INSERT A NEW SWANSON FINGER JOINT.
Additional Manufacturer Narrative
PLEASE REFER TO H6 DEVICE CODE. THE REPORTED EVENT COULD CONFIRMED BASED ON IMAGE SHARED BY THE SURGEON IN THE COMMINATION LOG THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER WITH THE IMAGE SHARED BY SURGEON IT CAN BE OBSERVED THAT THE IMPLANT IS BROKEN A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE FINGER JOINT THAT APPEARED TO BE DAMAGED ON THE DISTAL END OF THE PROSTHESIS. THE OPERATION WAS TO REMOVE THE IMPLANT THAT WAS IMPLANTED 2 MONTHS AGO AND INSERT A NEW SWANSON FINGER JOINT.