Guide Wire Kit, 2.0/2.4 Cannulated Screws GWK 100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840118110822), received between Dec 28, 2016 and Aug 18, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2017Material Fragmentation; Difficult to Remove; Failure to Advance; Material Fragmentation; Difficult to Remove; Failure to Advance

  CSD 006 CANNULATED SCREWDRIVER, T6 LOT 2014000720 PART OF GWK 100 GUIDE WIRE KIT BROKE DURING INSERTION OF A CANNULATED SCREW. THE CASE WAS UNABLE TO BE FINISHED DUE TO LACK OF A NEW SCREWDRIVER, THE CANNULATED SCREW IS NOW SITTING 1 MM ABOVE THE BONE. DUE TO THE ANGLE OF INSERTION, THE K-WIRE WAS BENT. WHEN TRYING TO REMOVE THE K-WIRE, THE K-WIRE BECAME STUCK AND BROKE AT THE END. THE K-WIRE WAS UNABLE TO BE REMOVED AND REMAINS WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient; Irritation

  MAUDE report 6805407 ↗
• MalfunctionDec 28, 2016Fracture; Fracture

  GWK 100 CANNULATED DRIVER BROKE DURING IPJ FUSION. THE CANNULATED DRIVER WAS INSERTING A 20 MM CANNULATED SCREW OVER THE GUIDEWIRE WHEN THE CANNULATED DRIVER TIP BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6211026 ↗