SHEATH HANDLE, SUPRAPATELLAR 0641-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665027617), received between Aug 8, 2025 and Aug 8, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 8, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON 07/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 0641-000 SHEATH HANDLE ASSEMBLY'S SUPRA PATELLAR DISPOSABLE SHEATH WAS ATTACHED THE GRAY T PORTION WITH THE BLACK HANDLE. THE SHEATH WAS INSERTED INTO THE KNEE AND THE TIBIA IMN WAS COMPLETED. WHEN THE SHEATH WAS REMOVED AT THE END OF THE CASE THE SILVER BUTTON THAT HOLDS THE SUPRA PATELLAR SHEATH AND TOP TOGETHER WAS BROKEN OFF AND LOCATED ON THE FLOOR. AN XRAY WAS OBTAINED TO MAKE SURE THAT NO PIECES OF THE DEVICE WERE IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TIME OR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748443 ↗