NA 2108352000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540042415), received between Feb 2, 2024 and Feb 7, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT BLADE BROKE AT THE MOUNT DURING A TOTAL JOINT PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS AN X-RAY PERFORMED AND A FRAGMENT OF BLADE NEEDED TO BE REMOVED FROM THE CLOSED SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658299 ↗
• InjuryFeb 2, 2024

  STRYKER 2108 SERIES SAGITTAL BLADE TINES (WHERE IT CONNECTS TO HANDLE, NOT PATIENT SAW END) BROKE OFF INTO THE STERILE FIELD. REQUIRED A LOT OF TIME TO IDENTIFY WHERE THE METAL FRAGMENT WAS FROM AND AFTER X-RAY CONFIRMATION, THE INCISION OF ARTHROPLASTY HAD TO BE REOPENED TO RETRIEVE THE FRAGMENT. NOT ONLY IS THIS DANGEROUS TO THE PATIENT BUT ARTHROPLASTY IMPLANTS ARE ALREADY VERY SUSCEPTIBLE TO INFECTION AND CLOSURE SHOULD BE QUICK TO REDUCE THE RISK. MUCH TIME WAS SPENT ON LOCATING AND THANKFULLY THE PATIENT WAS NOT HURT BUT HAD LONGER ANESTHESIA TIME AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641012 ↗