Tiger 212-40-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021911), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 malfunction.

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.

• MalfunctionJun 18, 2018Break; Entrapment of Device; Material Integrity Problem; Material Integrity Problem

  WHILE PERFORMING A LAPIDUS PROCEDURE ON A MALE PATIENT IN HIS (B)(6) WITH AVERAGE BONE QUALITY, THE SURGEON EXPERIENCED A 212-40-003 DRIVER (LOT # 19592-01-01) BREAK WHILE INSERTING A 202-30-034 TIGER HEADLESS SCREW. THE SALES REPRESENTATIVE AT THE CASE, NOTED THAT THE SURGEON PRE-DRILLED AND PROX-DRILLED PRIOR TO INSERTION. THE SURGEON UTILIZED A K-WIRE AND INSERTED THE 202-30-034 TIGER SCREW WITHOUT ANY ISSUES. ONCE THE SURGICAL SITE WAS SUTURED, IT WAS REALIZED THAT THE 212-40-003 DRIVER TIP HAD BROKEN OFF DURING SURGERY. FLUORO WAS UTILIZED TO DETECT THE BROKEN PIECE THAT REMAINED IN THE PATIENT (X-RAY ATTACHED). THE SALES REPRESENTATIVE IS FOLLOWING UP WITH THE SURGEON TO SEE HOW HE PLANS TO MOVE FORWARD. INFORMATION HAS NOT BEEN RECEIVED AT THIS TIME. THE BROKEN 212-40-003 DRIVER WILL BE RETURNED TO FOR REVIEW WHILE THE 202-30-034 TIGER HEADLESS SCREW AND DRIVER TIP REMAINS IN THE PATIENT.

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

  MAUDE report 7612352 ↗