Formula 0375542000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327061819), received between Jul 19, 2018 and Dec 30, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (6 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN BODY WAS FOUND IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927427 ↗
• MalfunctionDec 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SHAVER INNER COMPONENT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE METAL FRAGMENTS LOCATED IN THE JOINT AREA WERE ASPIRATED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872876 ↗
• MalfunctionOct 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY THE RESECTOR CUTTER BROKE INSIDE THE KNEE. THERE WAS EXTENDED OPERATING TIME FOR RETRIEVAL OF THE BROKEN PIECE. X-RAY OF THE KNEE IN THE RECOVERY ROOM VERIFIED THE ABSENCE OF FOREIGN BODIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367904 ↗
• MalfunctionAug 27, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INNER CYLINDER OF THE SHAVER GOT STUCK INSIDE THE OUTER CASING AND BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT'S BODY. IT IS NOT LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907461 ↗
• MalfunctionJan 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BREAKING DURING THE PROCEDURE. THE PIECES WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163708 ↗
• MalfunctionJun 7, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489309 ↗
• MalfunctionMar 7, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862108 ↗
• MalfunctionNov 9, 2022Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED DURING THE PROCEDURE. PLEASE NOTE, NO PIECE OF THE DEVICE BROKE OFF INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761991 ↗
• MalfunctionAug 18, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

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

  MAUDE report 12339951 ↗
• MalfunctionAug 18, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

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

  MAUDE report 12339949 ↗
• MalfunctionApr 20, 2021Break; Break

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

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

  MAUDE report 11695128 ↗
• MalfunctionMar 16, 2021Contamination; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

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

  MAUDE report 11496038 ↗
• MalfunctionMar 16, 2021Contamination; Device Contaminated During Manufacture or Shipping; Contamination

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

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

  MAUDE report 11496034 ↗
• MalfunctionDec 17, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

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

  MAUDE report 11032395 ↗
• MalfunctionNov 17, 2020Contamination; Contamination; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

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

  MAUDE report 10857300 ↗
• MalfunctionSep 9, 2019Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN STERILE PACKAGING.

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

  MAUDE report 8976354 ↗
• MalfunctionApr 15, 2019Break

  IT WAS REPORTED THAT THE TIP BROKE DURING A PROCEDURE. IT WAS CONFIRMED THAT ALL PIECES WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8515202 ↗
• MalfunctionOct 3, 2018Break

  IT WAS REPORTED THAT THE TIP BROKE. NO PIECES FELL INSIDE THE JOINT SPACE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931231 ↗
• MalfunctionSep 10, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7862053 ↗
• MalfunctionJul 19, 2018Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703159 ↗