DJO SURGICAL 802-05-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446365891), received between Feb 20, 2023 and Jun 30, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K212941); they may or may not involve this specific model.

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.

• MalfunctionJun 30, 2023Material Integrity Problem; Material Integrity Problem

  INSTRUMENT FAILURE - PATELLA DRILL GOT WEDGED INTO THE DRILL GUIDE.

  Patient problems: Insufficient Information

  MAUDE report 17243851 ↗
• InjuryFeb 20, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  INSTRUMENT FAILURE - SIGNIFICANT ADVERSE EVENT, PATELLA DRILL GOT WEDGED INTO THE BRAND NEW DRILL GUIDE ON THE FIRST HOLE WE TRIED TO PUT IT THROUGH. DOC COULDN'T GET IT OUT AND WE HAD TO OPEN A NEW PAN.

  Patient problems: Insufficient Information

  MAUDE report 16406272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212941. One submission often covers many models, so check the product and lot details in each record.

• Z-1384-2023 · Feb 28, 2023 · Open, Classified
  EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108