NA 9653-68-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295246817), received between Mar 26, 2019 and Dec 27, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  THE CALCAR REAMERS ARE BLUNT DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054973 ↗
• MalfunctionDec 27, 2022Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  THE CALCAR REAMERS ARE BLUNT DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054968 ↗
• MalfunctionDec 27, 2022Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  THE CALCAR REAMERS ARE BLUNT DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054956 ↗
• MalfunctionDec 27, 2022Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  THE CALCAR REAMERS ARE BLUNT DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054943 ↗
• MalfunctionDec 27, 2022Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  THE CALCAR REAMERS ARE BLUNT DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054848 ↗
• MalfunctionDec 27, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THE INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054363 ↗
• MalfunctionDec 27, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THE INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054352 ↗
• MalfunctionDec 27, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THE INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054339 ↗
• MalfunctionDec 27, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THE INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054324 ↗
• MalfunctionMar 26, 2019Component Missing; Component Missing

  DISCARDED INSTRUMENTS FROM A C STEM AMT CONSIGNMENT KIT DISCARDED MAKING THE KIT INCOMPLETE AND NOT USABLE. MISSING ITEMS: HOHMANN RETRACTOR 2181-10-000, PINNACLE ALIGNMENT ROD 9653-68-000, BOX CHISEL SMALL 2002-31-000, STEM INTRODUCER 2522-00-502, 36MM -2 TRIAL HEAD 2531-5-0000.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451516 ↗