NA 72202825Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554000443), received between Sep 4, 2020 and Dec 23, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT, IN AN ARTHROSCOPIC SURGERY, WHEN IT WAS TRYING TO REMOVED THE OTHER DEVICE, THE ARTHROSCOPIC NEEDLE ST ENDED UP LOCKING, RESULTING IN THE BREAKAGE OF THE DEVICE. THE PIECES WERE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY OF 40 MIN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067304 ↗
• InjurySep 4, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, WHEN USING THE "ARTHROSCOPIC NEEDLE ST", THE DOCTOR SPOKE WHEN HITTING THE PRODUCT ON THE BONE AND THE NEEDLE HIT THE BONE AND BROKE. ALL THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10495737 ↗