FMS 283229Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705027194), received between Jun 11, 2020 and Mar 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE 2.7MM MINI ULTRA-AGGER PLUS 5PK DEVICE SNAPPED WHILE IN USE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562464 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWEDEN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE OUTER SLEEVE OF THE 2.7MM MINI ULTRA-AGGR PLUS 5PK DEVICE BROKE IN TWO PIECES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520439 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WERE METAL ABRASIONS IN THE WRIST JOINT WHILE USING THE 2.7MM MINI ULTRA-AGGR PLUS 5PK DEVICE. ALL THE FRAGMENTS WERE REMOVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637258 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED BY SALES REPRESENTATIVE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ELBOW SCOPE AND UTILIZING THE MITEK 2.7MM MINI ULTRA-AGGRESSIVE BLADE PLUS(2.7MM MINI ULTRA-AGGR PLUS 5PK) FOR HIS SHAVER. DURING ITS USE, WE NOTICED THE BLADE WAS NOT SPINNING INSIDE OF THE SHAVER SHEATH. UPON REMOVING IT FROM THE JOINT, WE DISASSEMBLED THE SHAVER AND FOUND THE BLADE INSIDE TO BE BROKEN IN HALF. THE ITEM WAS DISCARDED AND ANOTHER OPENED. THERE WAS A SURGICAL DELAY OF 2 MINUTES. NO PATIENT HARM OCCURRED AND ALL BROKEN PIECES WERE RECOVERED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10143548 ↗