SPECIALIST 96-6648Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295249344), received between Nov 6, 2017 and Feb 18, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON PERFORMED A PRIMARY KNEE CASE USING THE ATTUNE REVISION AND NOILES SROM HINGE. THE BROACH REAM CONNECTION AND MODIFIED HUDSON INSTRUMENTS WERE NOT ABLE TO TURN AND CUT INTO THE FEMUR. THERE WAS A 10 MINUTE DELAY TO THE CASE, AND THE SURGEON CARRIED ON WITH THE PROCEDURE NO OTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399251 ↗
• MalfunctionMar 22, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  T-HANDLE WON'T RETAIN REAMERS/BROKEN CONNECTION.

  Patient problems: Insufficient Information

  MAUDE report 18961886 ↗
• MalfunctionAug 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 REAMER ADAPTER AND T HANDLE WERE WORN. THE INCIDENT CAUSED AT LEAST 15-20MINUTES DELAY TO THE SURGERY AS THE SURGEON HAD DIFFICULTY USING AND PROGRESSING THE REAMERS, DOWN THE TIBIA AND UP THE FEMUR. THERE WAS NO OVERALL DETRIMENTAL EFFECT TO THE SURGERY FOR THE PATIENT AND THE END OUTCOME WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 17550662 ↗
• MalfunctionJul 18, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ADAPTOR HAS ¿ROUNDED OFF¿ FROM LONG TERM USE. THIS MEANS THAT THEY OFTEN DISCONNECT DURING USE AND THE REAMERS CAN BECOME STUCK AS THEY JUST SPIN IN THE MECHANISM AND CAN¿T LOCK IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341193 ↗
• MalfunctionMay 4, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CHUCK END HAS ROUNDED OFF WITH LONG TERM USE AND NOW GETS STUCK TO ATTACHMENTS WITH GREAT DIFFICULTY TO REMOVE OR THE ATTACHMENTS SPIN DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867731 ↗
• MalfunctionJan 17, 2023Naturally Worn; Naturally Worn

  IT WAS FOUND PREOPERATIVELY THAT ON (B)(6) 2023 THAT THE PAINT ON THE T-HANDLE IN QUESTION HAD PEELED OFF AND THE SURFACE WAS ROUGH. THE T-HANDLE HAD PREPARED FOR THE SURGERY DATED (B)(6) 2022. THE T-HANDLE IN QUESTION IS NOT USED AND A REPLACEMENT IS BEING ARRANGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183553 ↗
• MalfunctionMar 24, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT T HANDLE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13889237 ↗
• MalfunctionMar 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT BOTH OF THE T-HANDLES LISTED BELOW ARE STRIPPED AND WILL NOT HOLD A REAMER FOR THE DOCTOR TO PERFORM PROPER REAMING. THE SURGEON REQUESTED A NEW ONE TO REPLACE. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED. THE REAMER IS STRIPPED AND WILL NOT HOLD A T-HANDLE FOR PROPER REAMING. SURGEON HAS REQUESTED TO BE REPLACED. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711214 ↗
• MalfunctionNov 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781041 ↗
• MalfunctionJun 25, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE MODIFIED HUDSON ADAPTER AND T HANDLE REPEATEDLY SLIPPED WHEN REAMING THE TIBIA AND FEMUR DURING REVISION TOTAL KNEE.

  Patient problems: Not Applicable

  MAUDE report 8730662 ↗
• MalfunctionMar 1, 2019Naturally Worn; Naturally Worn

  T-HANDLE WAS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383033 ↗
• MalfunctionSep 14, 2018Naturally Worn; Naturally Worn

  PRODUCT (B)(4) WAS RECEIVED WITH (B)(4) BUT WAS NOT REPORTED WITH THAT PC. FUNCTIONAL EVALUATION OF THE RETURNED T-HANDLE WITHOUT MATING A COMPONENT FOUND THE LOCKING MECHANISM TO FUNCTION WITH NO RESTRICTIONS. FUNCTIONAL EVALUATION WITH A RETAINED REAMER FOUND THE INSTRUMENT TO ASSEMBLE, RETAIN, AND DISASSEMBLE WITH NO RESTRICTIONS. OVERALL APPEARANCE EXHIBITED NORMAL WEAR MARKS AND SCRATCHES DUE TO NORMAL USAGE AND SERVICING. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED FAILURE MODE, HOWEVER, INDICATIONS OF DEVICE WEAR THROUGH NORMAL USE AND SERVICING IS EVIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876253 ↗
• MalfunctionAug 8, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT HUDSON T-HANDLE IS STRIPPED AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762161 ↗
• MalfunctionMar 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE REVISION REAMER T-HANDLE WAS USED IN THE CASE TO REMOVE REAMERS FROM THE CANAL THAT WERE PLACED IN THE CANAL WITH POWER REAMER. IT LATCHED TO THE REAMER TO ALLOW IT TO BE REMOVED, BUT THE MECHANISM DOES NOT FUNCTION TO TWIST THE T-HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308999 ↗
• MalfunctionNov 6, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SP2 REAMER T-HANDLE STRIPPED.

  Patient problems: No Information

  MAUDE report 7005288 ↗