Formula 0375545000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327061796), received between May 16, 2017 and Sep 17, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810268 ↗
• MalfunctionMar 30, 2026Overheating of Device

  IT WAS REPORTED THAT DURING USE, THE KNIFE LEFT BLACK MARKS ON SOFT TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736442 ↗
• MalfunctionFeb 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE DID NOT FALL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453601 ↗
• MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435904 ↗
• MalfunctionJan 24, 2025Device 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 21231545 ↗
• MalfunctionAug 23, 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 20055545 ↗
• MalfunctionFeb 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699502 ↗
• MalfunctionDec 19, 2023Nonstandard Device; Device Contaminated During Manufacture or Shipping; Nonstandard Device; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360626 ↗
• MalfunctionSep 29, 2023Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844943 ↗
• MalfunctionSep 29, 2023Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844941 ↗
• MalfunctionAug 24, 2022Material Fragmentation

  DURING PROCEDURE WHILE THE SURGEON WAS USING THE STRYKER ARTHROSCOPIC SHAVER, THE BLADE (REF# 0375-545-000, LOT # 22052CE2) WAS NOTED TO BE SHEDDING METAL DEBRIS. THE SURGICAL SITE WAS THOROUGHLY IRRIGATED. SHAVERS WITH THE SAME LOT NUMBER WERE ALL REMOVED FROM INVENTORY BY STAFF. MANUFACTURER RESPONSE FOR BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL, FORMULA (PER SITE REPORTER). ALL SHAVERS WITH THE SAME LOT NUMBER WERE REMOVED FROM INVENTORY AND THE STRYKER REP WAS NOTIFIED OF THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15282296 ↗
• MalfunctionJun 9, 2022Contamination; Contamination; Device Contamination with Chemical or Other Material

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

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

  MAUDE report 14642630 ↗
• InjuryJan 5, 2022Break

  IT WAS REPORTED THAT THE DEVICE BROKE AND PIECES POTENTIALLY REMAINED IN THE SHOULDER.

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

  MAUDE report 13170682 ↗
• MalfunctionNov 22, 2021Break; Break

  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 12858040 ↗
• MalfunctionJun 15, 2021Contamination; Contamination

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

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

  MAUDE report 12001494 ↗
• MalfunctionJun 2, 2021Break

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

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

  MAUDE report 11925153 ↗
• MalfunctionMar 16, 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 11496040 ↗
• MalfunctionDec 9, 2020Break

  IT WAS REPORTED THAT THE INNER TUBE TIP OF THE DEVICE SPLITTING DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

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

  MAUDE report 10979884 ↗
• MalfunctionNov 3, 2020Break

  PER INVESTIGATION RESULTS, THE BREAK HAPPENED AT THE INNER TUBE AND NO PIECES WERE MISSING. THE INNER TUBE WOULD NOT BE ABLE TO COME OUT AND FALL INTO THE JOINT. THIS EVENT DESCRIPTION MOST LIKELY INDICATES ¿LOOSE PIECES (TIP BREAKING / TUBE BREAKING/ PLASTIC BREAKING)¿. THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED. THEREFORE MAKING THIS EVENT NOT REPORTABLE.

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

  MAUDE report 10782181 ↗
• MalfunctionDec 17, 2019Break

  IT WAS REPORTED THE DEVICE BROKE OFF IN THE PATIENT DURING THE PROCEDURE. THE PIECE WAS RETRIEVED. THERE WAS NO PATIENT . INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

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

  MAUDE report 9484355 ↗
• MalfunctionJul 16, 2019Contamination /Decontamination Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793346 ↗
• MalfunctionMay 16, 2017Break; Detachment Of Device Component; Entrapment of Device

  PATIENT HAVING ARTHROSCOPY PROCEDURE; CUTTER WAS BEING USED TO SHAVE CARTILAGE WHEN THE TIP OF THE DEVICE BROKE OFF IN PATIENT'S SHOULDER. BROKEN TIP WAS SUCCESSFULLY RETRIEVED BY SURGEON.

  Patient problems: Foreign Body In Patient

  MAUDE report 6575492 ↗