PHYSICA system 9095.11.A90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390104449), received between Jul 30, 2019 and Jul 30, 2019 — 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 16, 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.

• MalfunctionJul 30, 2019Break

  INTRA-OPERATIVE ISSUE OCCURRED DURING TOTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2019. DURING SURGERY, THE HEADLESS TWISTED PIN CODE 9095.11.A90, LOT #1706834 WAS INSERTED INTO A HOLE OF CUTTING GUIDE ON FEMORAL DISTAL SIDE USING A POWER PIN DRIVER. THE PIN WAS SPUN AROUND BUT CANNOT BE FIXED BECAUSE ITS END PART WAS FOUND TO BE BROKEN. SURGERY WAS PROLONGED OF 2-3 MINUTES AND THEN COMPLETED USING ANOTHER HEADLESS TWISTED PIN. EVENT OCCURRED IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 8840854 ↗