NA 210192Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486031916), received between Jul 13, 2018 and Nov 8, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2019Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  SMILEY RETRACTOR DAMAGED AND NEEDS REPLACEMENT. CASE TYPE: PKA (MICS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9295411 ↗
• MalfunctionAug 29, 2019Dent in Material; Material Integrity Problem; Dent in Material; Material Integrity Problem

  SMILEY RETRACTOR BADLY DAMAGED DUE TO SAW BLADE. INTERACTION DURING TKA CUTS. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946567 ↗
• MalfunctionOct 16, 2018Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  GAUGES IN RETRACTOR FROM SAW. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7970482 ↗
• MalfunctionJul 13, 2018Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  NOTICED IN CPD THAT THE TWO RIGHT ANGLED RETRACTORS IN THE MAKO BLACK LEG HOLDER SET ARE SEVERELY DAMAGED DUE TO BEING HIT BY THE SAW BLADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687181 ↗