Formula 0375638000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327061994), received between Sep 18, 2018 and Feb 3, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Fragmentation

  IT WAS REPORTED THAT A CHIPPED SHAVER TIP WAS DETECTED DURING SURGERY. THE SHAVER TIP WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE SURGERY ITSELF WAS COMPLETED WITHOUT ISSUE. THE SALES REP WAS CONTACTED AND CONFIRMED THAT ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252864 ↗
• MalfunctionDec 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INNER SHAVER BLADE CUTTING TIP BROKE OFF WHEN SHAVING. THE METAL PIECE WAS ABLE TO BE RETRIEVED. THEY OPENED UP ANOTHER SHAVER BLADE TO GET THROUGH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842518 ↗
• MalfunctionAug 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THAT SHAVER TIP BROKE OFF WHILE IN JOINT. THE PART WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925145 ↗
• MalfunctionAug 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING A CASE, 1 OF THE STRYKER SMALL JOINT CUTTER BROKE WHILE BEING USED ON A PATIENT, THE SURGICAL TEAM WERE ABLE TO REMOVE THE BIT THAT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22913332 ↗
• MalfunctionFeb 28, 2023Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452389 ↗
• InjuryJun 8, 2022Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND A PIECE WAS LEFT IN THE PATIENT. THE PATIENT NEEDED TO BE BROUGHT BACK TO SURGERY FOR RETRIEVAL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634619 ↗
• MalfunctionSep 18, 2018Break

  IT WAS REPORTED THAT THE TIP BROKE. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7887368 ↗