FREE GLIDING SCFE SCREW SYSTEM SCF-SFT373Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540194008008), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (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.

• InjuryNov 24, 2020Fracture; Device Handling Problem; Fracture; Device Handling Problem

  THE 7.3 SCREW WAS ASSEMBLED ONTO THE 7.3 GREEN DRIVER. THE ASSEMBLED SCREW WAS INSERTED INTO THE REAMED CANAL OVER 2.4 GUIDEWIRE. AFTER IT WAS FULLY INSERTED, THE SURGEON DISENGAGED THE DRIVER FROM THE SCREW AND TOOK X-RAYS TO CONFIRM THE POSITION. NOT SATISFIED WITH THE POSITION, THE SURGEON PROCEEDED TO RE-ENGAGE THE DRIVER TO THE SCREW TO BACK IT UP. AFTER TRYING A FEW TIMES, THE DRIVER THREADS WOULD NOT RE-ENGAGE THE SCREW. NONETHELESS, HE WAS STILL ABLE TO USE THE DRIVER TO RETRACT THE SCREW TO THE DESIRED POSITION. AFTER THE DRIVER WAS HANDED BACK TO THE SCRUB NURSE, SHE BEGAN TO DISASSEMBLE IT, AND AT THIS POINT, IT WAS OBSERVED THAT THE THREAD ON THE END OF THE INTERNAL SHAFT HAD BROKEN OFF. THE BROKEN PIECE COULD NOT BE FOUND IN THE STERILE FIELD. ALSO, THE BROKEN FRAGMENT DID NOT SHOW ON X-RAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10895377 ↗