inforMED
MalfunctionHXI

K-WR SGL END TRCR TIP SMTH 1.6X150MM

Received Jul 27, 2026 · Event occurred May 17, 2024

Report 3008650117-2026-00443 · MDR key 50047038

Device

Generic name

Passer, Wire, Orthopedic

Manufacturer

Paragon 28

Catalog number

P99-192-1615

Product problems

  • Fracture

Patient

Not reported

  • Foreign Body In Patient

Narrative

Description of Event or Problem

It was reported that during a procedure, 2 k-wires fractured; one had fragment retained by the patient and one did not. No fragments of this device were left in the patient. Attempts have been made and no additional information has been provided.

Additional Manufacturer Narrative

CMP-1032325This MDR is submitted late after remediation efforts and a retrospective review of complaint reportability. D4: Attempts have been made to gather all product identification information, and no further information has been provided. The reported event was confirmed via examination of provided photos. The device was fractured. A review of the device history records was unable to be performed as lot number was not provided. A definitive root cause could not be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer Biomet will continue to monitor for trends.