SPECIALIST 96-6315Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295247791), received between Oct 5, 2017 and Oct 13, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Break; Break

  INSTRUMENT BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600840 ↗
• MalfunctionAug 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDE DID NOT HAVE THE ADJUSTMENT SCREW TO USE THE INTRAMEDULLARY GUIDE FOR THE RESPECTIVE TIBIAL CUT. IT WAS SOLVED WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280044 ↗
• MalfunctionOct 30, 2020Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT UPON SETTING UP FOR DISTAL FEMORAL REPLACEMENT THE PART OF TIBIAL CUTTING JIG WOULD NOT WORK. ANOTHER TRAY HAD TO BE OPENED FOR THE CASE. THIS PIECE HAS SOME ROUGH AREAS AND WILL NOT GLIDE PROPERLY. SALES REP ALSO FELT THAT THE METAL PIECE THAT ALLOWS ADJUSTMENT WILL NOT ALLOW YOU TO PRESS IT FOR SMOOTH ADJUSTMENT. THIS DID NOT DELAY THE CASE, THEY HAD ANOTHER ONE TO OPEN. NOBODY WAS INJURED BY DAMAGED PIECE, AND I AM RETURNING. I SEE NO LOT NUMBER JUST 204*.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763239 ↗
• MalfunctionJan 2, 2019Component Missing; Appropriate Device Problem Term/Code Not Available; Component Missing; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREW FELL OUT OF THE IM TIBIAL GUIDE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209038 ↗
• MalfunctionFeb 12, 2018Difficult to Insert; Difficult to Insert

  REVISION RIGHT KNEE REPLACEMENT , SURGEON; (B)(6), (B)(6) HOSPITAL (B)(6) 2018. THE L SHAPED ASSEMBLY COULD NOT FIT THROUGH THE ALIGNMENT DEVICE, THEREFORE THE JIG COULD NOT BE USED. ANOTHER INSTRUMENT KIT NEEDED TO BE USED TO PERFORM THE CUTS. NO DELAY TO PROCEDURE. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263049 ↗
• MalfunctionOct 5, 2017Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE TIBIAL INSTRUMENT HAS A SMALL SCREW THAT HAS GONE MISSING.

  Patient problems: No Information

  MAUDE report 6915045 ↗