Screw Sheath 0643Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665027365), received between Nov 2, 2021 and Nov 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 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.

• MalfunctionNov 2, 2021Material Separation

  ON 10/12/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT WHEN THE SURGEON WAS INSERTING THE 3.5 LOCKING SCREW IN THE PROXIMAL SHAFT OF THE TIBIA, THE 0643-000 SCREW SHEATH LOCKED AND THE TIP SHEARED OFF DURING FINAL FIXATION OF THE LOCKING SCREW. THE SURGEON WAS ABLE TO BACK OUT THE LOCKING SCREW AND USED FLUOROSCOPY IN ORDER TO REMOVE ALL FRAGMENTS OF THE 0643-000 FROM THE PATIENT. THIS WAS DURING A PILON FRACTURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW GUIDE AND USED THE SAME LOCKING SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 12737765 ↗