SPECIALIST 96-6384Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295248262), received between Oct 10, 2018 and Jan 3, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  THE TIBIAL TRAY INSERT IS DAMAGED, IT DOES NOT ALLOW TO GRASP THE TIBIAL PLATE, WEAR IS EVIDENCED AND PREVENTS THE CORRECT COUPLING. THERE WAS NO NEGATIVE CONSEQUENCE TO THE PATIENT OR IN THE PROCEDURE, SURGEON DECIDED TO PLACE THE TIBIA IMPLANT MANUALLY AND THEN IMPACT, BUT IT IS NECESSARY TO CHANGE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436161 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN WHERE IT CONNECTS WITH THE POSTERIOR TIBIAL IMPLANT. FOUND BROKEN IN SPD. IT WAS NOT USED IN SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949967 ↗
• MalfunctionApr 27, 2022Break; Break

  INSTRUMENT BROKE DURING IMPLANTATION. ALL PIECES WERE RETRIEVED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220354 ↗
• MalfunctionFeb 9, 2022Break; Naturally Worn; Break; Naturally Worn

  INSTRUMENT IS BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496088 ↗
• MalfunctionJan 7, 2022Break; Break

  RING AND SCREW MECHANISM IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196872 ↗
• MalfunctionDec 21, 2021Break; Break

  METAL PRONG BROKE OFF, NOT USED IN SURGERY. PIECE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053555 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT THE IMPACTOR BROKE DURING TIBIA IMPACTION. THE PART THAT BROKE WAS THE SMALL LIPPED PART THAT HOOKS THE ANTERIOR PORTION OF THE TIBIA. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649040 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT THE ONE OF THE TABS ON THE TIBIAL TRAY INSERTER HAS CHIPPED OFF. THIS DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959998 ↗
• MalfunctionNov 23, 2020Crack; Crack

  IT WAS REPORTED THAT SP2 POLY PS IMPACTOR HAS CRACKED FROM USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10888074 ↗
• MalfunctionNov 9, 2018Break; Break

  ATTACHED SLAPHAMMER 1 LIP ON INSTRUMENT BROKE AFTER A COUPLE BACK SLAPS THAT FIT INTO THE FIXED BEARING TIBIAL TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055432 ↗
• MalfunctionOct 17, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  DAMAGED ITEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974005 ↗
• MalfunctionOct 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL INSERTER WOULD NOT TIGHTEN ONTO THE TIBIAL BASE PLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953345 ↗