Device product
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
Z-0074-2024
Product summary
- Event
- Event 93024
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-0074-2024
Official wording
Reason: Device is breaking while in use, potential for patients to require a revision surgery.
Code information: UDI:00840118117432 Lot Number: 2304323076
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Device is breaking while in use, potential for patients to require a revision surgery.