SPECIALIST 96-6145Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295247005), received between Mar 12, 2018 and Feb 3, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE POSTERIOR SAW CAPTURE BROKE AWAY ON USE. ANOTHER BLOCK WAS OPENED FOR USE. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297536 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT THE CUTTING BLOCK BROKE AT (B)(6) HOSPITAL. NO DELAY OR HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689113 ↗
• MalfunctionOct 29, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SIZE 5 AP CUT GUIDE WAS BINDING WHEN TRYING TO PASS THE SAW THROUGH THE POSTERIOR CHAMFER SLOT. NO PIECES WERE BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695311 ↗
• MalfunctionJul 28, 2022Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  SIZE 5 CUTTING BLOCK HAS BEEN LOST FROM THEIR SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126058 ↗
• MalfunctionJun 13, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HOSPITAL HAVE REPORTED A DAMAGED INSTRUMENT THAT REQUIRES REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674539 ↗
• MalfunctionJun 6, 2022Naturally Worn; Naturally Worn

  THE BLOCK IS UNUSABLE DUE TO WEAR AND TEAR. SURGICAL DELAY OF 5 MINUTES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603149 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO TWO PARTS. SURGERY NOT DELAYED. PATIENT NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853207 ↗
• MalfunctionOct 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEMORAL CUTTING BLOCK CAPTURES WAS BENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10673015 ↗
• MalfunctionJan 29, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE SP2 AP CHAMF BLK POPUP R.H.SZ5 ANTERIOR FACE IS BENT INWARD, IT DOES NOT ALLOW A SAW BLADE TO PASS THROUGH THE BLOCK. THERE ARE NO PARTS BROKEN OFF OF THE INSTRUMENT AND IT IS BEING RETURNED TO DEPUY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643600 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT THE SP2 AP CHAMF BLK POPUP R.H.SZ5 ANTERIOR FLANGE CUTTING SLOT HAS BROKEN OFF AND NEEDS TO BE REPLACED. THIS PART WAS NOT USED ON A PATIENT AND IS BEING RETURNED TO DEPUY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813148 ↗
• MalfunctionApr 8, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  THE CUTTING GUIDE IS DEFORMED, SO IT GIVES AN IMPRECISE CUT. OVER TIME, THE OPENINGS (FOR THE MOTOR BLADES) OF THE CUTTING GUIDE WEAR OUT AND ARE NO LONGER STRAIGHT, WHICH CAN LEAD TO AN INACCURATE CUT OR MISALIGNMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492793 ↗
• MalfunctionApr 8, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  THE CUTTING GUIDE IS DEFORMED, SO IT GIVES AN IMPRECISE CUT. OVER TIME, THE OPENINGS (FOR THE MOTOR BLADES) OF THE CUTTING GUIDE WEAR OUT AND ARE NO LONGER STRAIGHT, WHICH CAN LEAD TO AN INACCURATE CUT OR MISALIGNMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492792 ↗
• MalfunctionJan 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE 4 IN 1 CUTTING BLOCK'S ANTERIOR AND POSTERIOR SLOTS WERE BENT BECAUSE THE SURGEON HIT THE BLOCK WITH A MALLET. THESE BENT SLOTS DID NOT ALLOW THE SAW BLADE TO PASS THROUGH THEM CORRECTLY AND THE BLOCK NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285238 ↗
• MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent

  THE CUTTING BLOCK IS DEFORMED AND THE CUT CAN BE BAD. PATIENT CONSEQUENCE? :NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8146166 ↗
• MalfunctionNov 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUTTING BLOCK WAS IMPINGING ON THE SAW BLADE NOT ALLOWING IT TO SLIDE THROUGH CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086701 ↗
• MalfunctionMar 12, 2018Collapse; Collapse

  AFTER YEARS AND YEARS OF USE, THE CHAMFERS HAVE COLLAPSED ON THIS BLOCK, SO IT IS IMPOSSIBLE TO MAKE THE CUTS. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7332340 ↗