SPECIALIST 96-6131Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295246954), received between Oct 13, 2017 and Jul 17, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SIZER WON¿T TURN SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333155 ↗
• MalfunctionOct 17, 2019Mechanical Jam; Naturally Worn; Physical Resistance/Sticking; Mechanical Jam; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HOLES FOR DRILL PINS ARE FRAYED AND DOESN¿T ALLOW A DRILL BIT TO PASS THROUGH THE HOLE WITHOUT BINDING UP. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205010 ↗
• MalfunctionMay 3, 2019Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THE FEM SIZER SIGMA WAS REPORTED WITH NO ALLEGATION PROVIDED. NO DELAY. VISUAL INSPECTION UPON RECEIPT FOUND BOTH ADJUSTMENT KNOBS TO BE SEIZED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579262 ↗
• MalfunctionOct 13, 2017Material Distortion; Material Distortion

  IT WAS REPORTED THAT THE FEMORAL SIZER HAS BURR AND DRILL BIT WILL NOT PASS THROUGH.

  Patient problems: No Information

  MAUDE report 6947817 ↗