SPECIALIST 96-6376Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295248194), received between Oct 12, 2020 and Oct 6, 2022 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL WAS WORN AND BENT AND WOULD NOT PROPERLY SEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550292 ↗
• MalfunctionOct 12, 2020Break; Mechanical Jam; Break; Mechanical Jam

  YESTERDAY IN SPIRE THAMES VALLEY HOSPITAL, THE TIBIA DRILL AND GUIDE BECAME JAMMED, AND WHEN EVENTUALLY THEY CAME APART IT SEEMS A PIECE OF METAL HAS BROKEN OFF AS WELL. ITEM NUMBERS ARE 966376, AND ONE OTHER.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10666647 ↗