FREE GLIDING SCFE SCREW SYSTEM SCF-GWR320-CoCrRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540194008206), received between Feb 17, 2022 and Feb 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryFeb 17, 2022Material Fragmentation; Improper or Incorrect Procedure or Method; Material Fragmentation; Improper or Incorrect Procedure or Method

  DURING A BILATERAL INSERTION OF THE SLIDING SCFE SCREW, IT WAS NOTED AFTER REMOVING THE 2.0MM GUIDE WIRE THAT THE TIP OF THE THREADED PORTION WAS LEFT IN THE PATIENT DURING THE SECOND HIP. IT WAS NOT DEEMED TO BE IN THE WAY OF THE SCREW, AND THE SURGEON HAS DECIDED NOT TO REMOVE IT. BOTH SCREWS WERE INSERTED, AND THE OUTCOME OF THE SURGERY WAS GOOD AND AS PLANNED. THE TIP OF THE WIRE IS OUTSIDE OF THE SCREW, AS THE DISTRIBUTOR UNDERSTOOD. THE HOSPITAL HAS RAISED THIS AS A FOREIGN BODY LEFT-IN-PATIENT INCIDENT. THE WIRE THAT BROKE HAD BEEN USED IN THE FIRST HIP AND WAS BEING USED BECAUSE THE OTHER WIRES (4 X SUPPLIED 2.0MM) WERE ALREADY BENT DURING THE SURGERY. SO, IT HAD ALREADY BEEN USED TO INSERT THE FIRST SCREW.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548818 ↗