NA 511.770Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982237743), received between Sep 16, 2021 and Sep 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 16, 2021Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CONNECTION BETWEEN THE TORQUE LIMITING ATTACHMENT DEVICE AND THE HANDLE FOR THE TORQUE LIMITER DEVICE WAS EASILY DISCONNECTED. IT WAS FURTHER REPORTED THAT THE SURGEON TOOK CARE IN HANDLING THE DEVICE AND COMMENTED THAT THERE MAY HAVE BEEN A PROBLEM WITH THE SHIPMENT INSPECTION. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480718 ↗