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NA 2108109001S1Recalls & reported problems

Stryker Corporation · 2108 Series Sagittal Blade (20.5 x 0.88 x 94.5mm) · 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 07613154354597), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 20, 2020Fracture; Fracture

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9733862 ↗

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