MalfunctionHSB
REDEMPTION DUO HINDFOOT NAIL SYSTEM
Received Oct 24, 2024 · Event occurred Oct 10, 2024
Report 20522108 · MDR key 20522108
Device
Generic name
Rod, Fixation, Intramedullary And Accessories
Manufacturer
Vilex LlcPatient
46 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
VILEX TRAY: REDEMPTION DUO HINDFOOT NAIL SET: HEEL CUP FELL OFF DURING ASSEMBLY. THIS PIECE CONTINUED TO FALL OFF WHEN ATTACHING THE LOCKING SCREWS FOR THE PATIENT IMPLANT. THE BASE OF THIS PIECE CRACKED DURING USE AND WOULD NO LONGER STAY IN PLACE WHILE LOCKING THE IMPLANT SCREW AND WOULD FELL OFF IN REPEATED ATTEMPTS OF USE. MANUFACTURER RESPONSE FOR HEEL CUP, VILEX: REDEMPTIONDUO HINDFOOT NAIL (PER SITE REPORTER). THEY WOULD BE RETRIEVING THE PRODUCT.