SPECIALIST 96-6152Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295247043), received between Aug 23, 2017 and Apr 8, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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.

• MalfunctionApr 8, 2019Material Deformation; Material Deformation

  THE CUTTING GUIDE WAS DEFORMED SO IT GIVES AN IMPRECISE CUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492692 ↗
• MalfunctionApr 8, 2019Material Deformation; Material Deformation

  THE CUTTING GUIDE WAS DEFORMED SO IT GIVES AN IMPRECISE CUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492691 ↗
• MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent

  IN THEATRE WITH THE SURGEON AT (B)(6), THE ATTACHED IMAGES SHOW A BENT PIN AND DEVICE PRODUCT/LOT CODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8146346 ↗
• MalfunctionAug 23, 2017Break; Break

  IT WAS REPORTED THAT THE 4 IN 1 POP UP CUT BLOCK WAS BROKEN DURING SURGERY. ANTERIOR POP UP SLOT BECAME LOOSE AND DISENGAGED.

  Patient problems: No Information

  MAUDE report 6814990 ↗