C-WIRE 00505004200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854029091), received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00505004200, C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE, WAS BEING USED ON (B)(6) 2024 DURING A FRACTURE OF THE DISTAL PHALANX OF THE MIDDLE FINGER AND THE ¿C-WIRE BROKE DURING INSERTION.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENTS DID FALL INTO THE SURGICAL SITE AND WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE BACKUP DEVICE. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047546 ↗