MINI IH4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327363241), received between Nov 11, 2021 and Nov 11, 2021 — 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.

• MalfunctionNov 11, 2021Break; Fracture; Break; Fracture

  AS REPORTED; "SURGEON WAS WANTING TO PLACE ORIGINAL SCREW IN AND THE SIZE WANTED WAS BACKORDERED AND DECIDED TO PLACE LARGER DIAMETER SCREW IN. PLACING SCREW IN VIA POWER AND RAN INTO POSITIONAL KWIRE AND BROKE TIP OFF OF SCREW. IN DOING SO BENT GUIDEWIRE THEN INSERTED ANOTHER SCREW AND BENT SECOND SCREW ON ORIGINAL GUIDE WIRE. SURGEON REMOVED WIRE AND PLACED ADDITIONAL SCREW. ISSUE WAS NOTICED WHEN SCREW WAS NOT ADVANCING."

  Patient problems: Insufficient Information

  MAUDE report 12794737 ↗

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