Device product
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Z-1678-2022
Product summary
- Event
- Event 90738
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 640 units
- Official record key
device-enforcement:Z-1678-2022
Official wording
Reason: Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
Code information: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Distribution pattern: US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Derived failure modes
-
Unknown
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time