NA 03.816.801Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034731124), received between Apr 1, 2020 and Apr 1, 2020 — classified as 1 malfunction.

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

• MalfunctionApr 1, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2020, DURING INSPECTION OF SET AT LOANERS DEPARTMENT IT WAS FOUND OUT THAT THE SCREW OF A STRONG ARM CONNECTOR WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DISTAL THREADS OF THE LOCKING NUT BROKE (NOT RETURNED) PREVENTING THE DEVICE FROM FUNCTIONING AS INTENDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9912269 ↗