NA 214.742Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982154422), received between Oct 26, 2021 and Oct 26, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryOct 26, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A 4.5 MM CANNULATED SCREW BROKE AT THE TIP OF THE SCREW WHEN THE SURGEON WAS PLACING SCREW-IN PATIENTS DISTAL HUMERUS. THE SURGEON HAD DRILLED APPROXIMATELY HALF OF THE TOTAL SCREW WITH A 3.2MM DRILL BIT BEFORE PLACING THE SCREW. IT WAS STATED THAT THE SURGEON DID NOT WANT TO RETRIEVE FRAGMENTS. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5 CANNULATED SCREW FULLY THREADED/42. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12700031 ↗