Knee Instruments 02.09.10.0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040785631), received between Sep 13, 2019 and Sep 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• MalfunctionSep 13, 2019Device Markings/Labelling Problem

  DURING THE PRIMARY KNEE SURGERY, THE SURGEON OBSERVED THAT THE SIZE 3-4 PUNCHER WAS MISSING THE ETCH MARKS USED TO MEASURE THE OFFSET. THE SURGEON WAS FINALLY ABLE TO MEASURE THE OFFSET WITHOUT THE ETCH MARKS BUT IT CAUSED A 50-MINUTE DELAY IN THE CASE. THE SURGEON WAS OBLIGED TO RELEASE THE TOURNIQUET AND TO WAIT TO PUT THE TOURNIQUET BACK UP TO CEMENT. THIS INSTRUMENT WAS FROM A CONSIGNMENT SET. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9030694 ↗