NA 2046-34-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295084396), received between Nov 20, 2019 and May 28, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2020Crack; Crack

  HOOK CRACKED DURING USE. SECOND HOOK AVAILABLE, NO SURGICAL DELAY OR HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097460 ↗
• MalfunctionNov 20, 2019Material Twisted/Bent; Material Twisted/Bent

  STRIPPED SCREWDRIVER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349340 ↗