Tiger 212-00-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021812), received between Dec 30, 2019 and Dec 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 18, 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 30, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  ON 12/02/2019, A TRILLIANT SURGICAL SALES REPRESENTATIVE CALLED SALES SUPPORT TO REPORT THAT THE LID OF A TIGER HEADLESS SCREW STERILIZATION TRAY BASE ASSEMBLY COULD NOT BE REMOVED FOR A CASE WHERE HE WAS PRESENT. SALES SUPPORT ATTEMPTED TO CONTACT THE SALES REPRESENTATIVE FOR MORE INFORMATION TWO (2) TIMES ON 12/04/2019, THREE (3) TIMES ON 12/05/2019, AND ONE (1) TIME ON 12/11/2019, BUT HAS NOT BEEN ABLE TO REACH HIM. THE TIGER HEADLESS SCREW STERILIZATION TRAY BASE ASSEMBLY WAS RETURNED TO CORPORATE FOR REVIEW ON 12/04/2019 WITH A NOTE FROM THE SALES REPRESENTATIVE THAT STATED, "THIS SET ARRIVED STERILE WRAPPED FROM A HOSPITAL WITH LID JAMMED AND UNABLE TO USE." SALES SUPPORT REVIEWED THE TRAY PRIOR TO DECONTAMINATION AND DID NOT HAVE ANY ISSUES REMOVING THE LID. ON 12/11/2019, THE SALES REPRESENTATIVE CALLED SALES SUPPORT WITH THE ADDITIONAL INFORMATION BELOW. DOCTOR 1 PERFORMED A BUNIONECTOMY AND THREE (3) HAMMERTOE CORRECTIONS AT FACILITY X ON (B)(6) 2019. IN PREPARATION FOR THE CASE, THE SALES REPRESENTATIVE HAD A TRILLIANT SURGICAL DISTRIBUTOR IN A DIFFERENT STATE SEND HIS PERSONAL TIGER HEADLESS SCREW STERILIZATION TRAY BASE ASSEMBLY DIRECTLY TO FACILITY X. THE STERILE PROC

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9530843 ↗