Tiger 202-20-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021539), received between Mar 21, 2018 and Mar 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K112737); 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.

• MalfunctionMar 21, 2018Patient-Device Incompatibility

  DURING A 5TH METATARSAL FRACTURE CASE ON A (B)(6) FEMALE, THE DOCTOR EXPERIENCED SOME BONE SPLITTING WHILE INSERTING A 202-20-018 TIGER HEADLESS CANNULATED SCREW. THE DOCTOR USED A K-WIRE IN THIS CASE, PRE-DRILLED, AND FULLY PROX DRILLED BEFORE INSERTING ANY OF THE SCREWS. ONE OF THE 202-20-018 SCREWS WENT IN WITHOUT ANY ISSUES. DURING INSERTION OF THE OTHER 200-20-018 SCREW INTO THE PATIENT, AND AS THE HEAD OF THE SCREW WAS BEING INSERTED, THE BONE BEGAN TO SPLIT. THE SPLIT OCCURRED NEAR THE OUTSIDE OF THE BONE AND THE SPLIT WENT ACROSS THE BONE REQUIRING THE DOCTOR TO REMOVE A PORTION OF BONE FROM THE PATIENT. THE DOCTOR THEN USED SOME BONE PUTTY IN ORDER TO FILL IN THE SPOT WHERE THE PIECE OF BONE WAS REMOVED FROM THE PATIENT. THE TRILLIANT REP AT THE CASE DID NOTE THAT THE DOCTOR UTILIZED A 2.4 MM PROX DRILL IN THIS CASE DUE TO PRIOR EXPERIENCE. THE DOCTOR THOUGHT THAT UTILIZING A LARGER PROX DRILL WOULD ALLOW FOR MORE COUNTERSINKING WHICH COULD ALLOW MORE ROOM FOR THE HEAD OF THE SCREW. BOTH 202-20-018 SCREWS REMAIN IN THE PATIENT AND WILL NOT BE REMOVED WHILE THE 2.4 MM PROX DRILL WAS BILLED FOR AND TOSSED AFTER THE CASE. THE 212-24-003 DRIVER WAS KEPT BY THE SALES REPRESENTA

  Patient problems: Bone Fracture(s)

  MAUDE report 7360403 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112737. One submission often covers many models, so check the product and lot details in each record.

• Z-1605-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger
• Z-1606-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combinatio
• Z-0609-2017 · Sep 2, 2016 · Terminated
  Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgic
• Z-2464-2015 · Jul 20, 2015 · Terminated
  Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System an