MINI IH2540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327362633), received between Dec 15, 2020 and Dec 15, 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.

• MalfunctionDec 15, 2020Fracture; Fracture

  DOCTOR PERFORMED A FEMORAL HEAD ORIF. WHILE HE WAS INSERTING A 2.5X40 HEADLESS STRYKER MINI SCREW, THE SCREW BROKE OFF LEAVING HALF OF IT IN THE PATIENT¿S BONE. ALSO, WHILE HE WAS INSERTING A 3.0X40 HEADLESS STRYKER MINI SCREW THE SCREW BENT SO IT WAS NOT ABLE TO INSERTED. ADDED TIME TO THE SURGERY (5-10 MINUTES). ADDITIONALLY REPORTED: THE SURGEON SWITCHED TO USING 3.5 NON-LOCKING SCREWS FROM THE VARIAX 2 CORE TRAY TO FINISH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008063 ↗

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