SPECIALIST 96-6147Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295247029), received between Oct 31, 2018 and Jun 26, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE STUCK IN NOTCH SIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340891 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT A SIGMA REMOVABLE HANDLE WAS BROKEN DURING A CASE. ALL PARTS OF THE INSTRUMENT WERE TOGETHER AND RETRIEVED. THIS CAUSED NO EFFECT ON THE CASE OR PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699974 ↗
• MalfunctionJul 23, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT RUST LIKE STAINS ON INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 19805814 ↗
• MalfunctionJul 23, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT RUST LIKE STAINS ON INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 19805804 ↗
• MalfunctionJul 23, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT RUST LIKE STAINS ON INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 19805762 ↗
• MalfunctionJul 23, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT RUST LIKE STAINS ON INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 19805746 ↗
• MalfunctionApr 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? THERE WAS NO PATIENT CONSEQUENCE. WE REALIZED THE PIECE WAS BROKEN BEFORE THE CASE AND WORKED AROUND IT. B. WAS THERE ANY SURGICAL DELAY DELAY RELATED TO THE EVENT? NO DELAY. THE SURGEON MADE SO WITHOUT THE ITEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212038 ↗
• MalfunctionJan 11, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BALL BEARINGS NO LONGER WORK ON THE HANDLE AND IT NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149139 ↗
• MalfunctionDec 28, 2020Structural Problem; Material Twisted/Bent; Structural Problem; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BALL BEARINGS NO LONGER POP IN AND OUT, SO THEY DID NOT LOCK INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076846 ↗
• MalfunctionJun 10, 2020Break; Break

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT'S RIGHT KNEE JOINT. DURING THE SURGERY, ONE OF THE REMOVABLE HANDLE (P/N: 966147) BROKE WHEN THE SURGEON DETACHED FEMORAL FINISHING GUIDE. THE HANDLE¿S CONNECTING POINT CAME OFF, AND A SPRING FELL OUT FROM INSIDE OF THE CONNECTING POINT. THE SURGEON USED THE HANDLE USUALLY WHEN THE BREAKAGE OCCURRED. THERE WAS NO PIECE IN THE BODY. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138513 ↗
• MalfunctionJul 15, 2019Crack; Device-Device Incompatibility; Material Twisted/Bent; Crack; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE RUBBER GASKET WAS CRACKED. STRIPPED/WON'T ENGAGE FEMORAL ADAPTER WON'T SNAP INTO AP BLOCK/SMALL LOCKING BALL MISSING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790744 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  HANDLE WON'T FIT INTO CUTTING BLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670656 ↗
• MalfunctionMay 1, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  INSTRUMENT WAS SHOW WEAR BASED ON AGE. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569114 ↗
• MalfunctionApr 4, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SP 2 4-1 CUTTING BLOCK HANDLE WAS BROKEN. THE HANDLE DID NOT LOCK INTO THE 4-1 CUTTING BLOCK DUE TO THE BALL BEARING FALLING OUT OF THE TIP OF THE HANDLE. NO PARTS WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483747 ↗
• MalfunctionApr 3, 2019Crack; Crack

  RUBBER GASKET DAMAGED. SEAL WAS DRY AND CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479614 ↗
• MalfunctionJan 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLES WERE NOT CONNECTING AND NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227527 ↗
• MalfunctionJan 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLES WERE NOT CONNECTING AND NEEDED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227521 ↗
• MalfunctionDec 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN SUBSTANCES WHICH WAS LIKE A CHUNK OR BLOOD CLOT CAME OUT ON FROM THE REMOVABLE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174773 ↗
• MalfunctionDec 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN SUBSTANCES WHICH WAS LIKE A CHUNK OR BLOOD CLOT CAME OUT FROM THE REMOVABLE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174722 ↗
• MalfunctionNov 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  FOREIGN SUBSTANCES CAME OUT OF THE REMOVABLE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077489 ↗
• MalfunctionNov 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  FOREIGN SUBSTANCES CAME OUT OF THE REMOVABLE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077478 ↗
• MalfunctionOct 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALANCED BLOCK HANDLE DOES NOT ENGAGE WITH THE BLOCK ANY MORE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023463 ↗