MINI IH3040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327362893), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionSep 11, 2020Fracture; Fracture

  AS REPORTED: "SURGEON INSERTED 1.15 K-WIRE DOWN CANAL OF 3RD METACARPAL. SCREW LENGTH WAS OBTAINED AFTER COUNTERSINKING DRILL BIT. 2.1MM WAS INSERTED DOWN CANAL AS FAR AS POSSIBLE. 3.0 10MM MINI HEADLESS SCREW WAS INSERTED. WHEN SCREW WAS HALFWAY DOWN CANAL, SCREWDRIVER WAS VISIBLY HARDER TO TURN. SHORTLY AFTER, THE SCREW BROKE MID SHAFT. ADDED A PLATE" TOTAL OF "120 MIN SURGERY TIME".

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10525087 ↗

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