MINI KN1115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327363258), received between Mar 1, 2022 and Mar 1, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K120493); they may or may not involve this specific model.

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.

• MalfunctionMar 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE MINI SCREW KWIRE (KN1115) BROKE WHILE INSERTING THE SCREW. THE WIRE WAS SEEN IN X-RAY FLOATING IN PATIENT¿S SOFT TISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13634120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120493. One submission often covers many models, so check the product and lot details in each record.

• Z-2679-2014 · Apr 25, 2013 · Terminated
  Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System