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Formula 0375637000Recalls & reported problems

Stryker Corporation · [Small-Joint Full Radius Cutter, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327062021), received between Jan 5, 2021 and Sep 15, 2023 — classified as 1 injury, 1 malfunction.

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

Most reported problems

Device problems

  • Break2
  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Insufficient Information1

Recent adverse event reports

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

  • InjurySep 15, 2023Break; Material Fragmentation; Break; Material Fragmentation

    IT WAS REPORTED THAT THE TIP OF A SMALL JOINT SHAVER BROKE OFF DURING PROCEDURE. THE TIP WAS NOT ABLE TO BE REMOVED AND REMAINED IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17760772 ↗
  • MalfunctionJan 5, 2021Break

    IT WAS REPORTED THAT THE INNER SHEATH BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11118018 ↗

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

All BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices →

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