SPECIALIST 96-6321Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295247852), received between Feb 18, 2019 and Mar 1, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW MECHANISM ON THE ALIGNMENT DEVICE THAT CONNECTS TO CUTTING BLOCK WOULDN¿T UNSCREW. THIS IS PREVENTING THE CUTTING BLOCK FROM BEING RELEASED. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THE EVENT AND SURGERY WAS NOT PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815248 ↗
• MalfunctionNov 9, 2023Break; Material Deformation; Break; Material Deformation

  THEY WERE NOT USED DURING SURGERY AND WHERE NOTICED AS BROKEN WHEN THE SETS WERE OPENED. NO PATIENT HARM. NO FRAGMENT RETENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099763 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUTTING BLOCK IS STUCK TO THE PROXIMAL EXTRAMEDULLARY ALIGNMENT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730240 ↗
• MalfunctionApr 28, 2022Incorrect Measurement; Incorrect Measurement

  INSTRUMENT DOES NOT MEASURE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14237860 ↗
• MalfunctionDec 3, 2019Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  TODAY, A PATIENT SURGERY WAS SCHEDULED AT THE (B)(6), IN FULL SURGERY WITH AN OPEN PATIENT THE TIBIAL CUTTING GUIDE NO. 966321 NUMBER 3 DID NOT ENTER THE LANE OF THE EXTERNAL CUTTING GUIDE 966311. DESPITE SEVERAL ATTEMPTS, THEY FAILED TO ASSEMBLE. THE SURGEON HAD TO MAKE THE CUT BY HOLDING THIS GUIDE FREEHAND SINCE HE HAD NO OTHER OPTION, HE WAS WITH AN OPEN PATIENT AND UNFORTUNATELY THE CUT WENT WRONG. THE SURGERY HAD AN ADDITIONAL DELAY OF APPROXIMATELY 01 HOUR AND 15 MINUTES THAN USUAL.

  Patient problems: Not Applicable

  MAUDE report 9402337 ↗
• MalfunctionMar 7, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED BY THE SPD THAT THE 3 DEGREE TIBIAL CUTTING BLOCK WAS WORN DOWN AND HAD WEAR ON THE EDGES CREATING SHARP CORNERS ON THE CUTTING SLOT. THIS IS A SAFETY HAZARD AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400352 ↗
• MalfunctionFeb 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SPD REFUSED TO PROCESS 3 DEGREE TIBIA CUTTING BLOCK BECAUSE IT WAS A SAFETY HAZARD. THE CORNER OF THE CUTTING SLOT HAD A SHARP EDGE OF METAL DUE TO WEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358437 ↗
• MalfunctionFeb 18, 2019Mechanical Jam; Mechanical Jam

  UPON ENTERING THE SURGERY IT IS EVIDENT THAT THE EXTRAMEDULLARY GUIDE OF TIBIA WAS SPLIT PIECE AND TIGHTEN THE CUTTING GUIDE N3. THE EQUIPMENT WAS DELIVERED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DISMANTLE, BUT WHEN THE SAFETY WAS BROKEN, IT WAS IMPOSSIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347329 ↗