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NA 2108382002Recalls & reported problems

Stryker Corporation · 2108 Series Sagittal Blade Flared, Ground (19.0 x 1.37 x 90.0mm) · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540940360), received between May 1, 2019 and May 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 1, 2019Break; Break

    IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESES PROCEDURE, THE BLADE BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT METAL DEBRIS REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8568931 ↗

Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.