FMS 283319Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705027231), received between Sep 30, 2019 and Dec 10, 2025 — classified as 1 injury, 7 malfunctions.

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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE IT WAS OBSERVED THAT THERE WAS A HAIR OR THREAD ON THE BLADE OF THE 3.5MM AGGRESSIVE PLUS DEVICE. IT WAS REPORTED THAT THE SURGEON CHANGED TO ANOTHER BLADE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771758 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCECTOMY IN DUO MODE PROCEDURE, IT WAS OBSERVED THAT THE SURGEON EXPERIENCED A MALFUNCTION WITH THE AGGRESSIVE 4.0MM 5PK DEVICE WHICH RESULTED IN METAL DEBRIS. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232924 ↗
• MalfunctionMar 29, 2024Device-Device Incompatibility; Output Problem; Device-Device Incompatibility; Output Problem

  IT WAS REPORTED FROM FRANCE THAT THE 3.5MM AGGRESSIVE PLUS 5PK DEVICE KNIFE STOPPED TURNING AND THE CHUCK COULD NOT BE REMOVED. . IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004039 ↗
• MalfunctionJan 31, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS NO SUCTION ON THE AGGRESSIVE BLADE PLUS DEVICE; AND THAT THERE WAS A BACKFLOW OF LIQUID. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 20 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271732 ↗
• MalfunctionSep 13, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC SYNOVECTOMY IN THE KNEE PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUCTION FEATURE ON THE AGGRESSIVE BLADE PLUS DEVICE WAS OUT OF ORDER RIGHT FROM THE BEGINNING OF THE PROCEDURE. 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 15412633 ↗
• MalfunctionNov 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A LUMP OF WHITE HARDENED LUBRICANT WAS ON THE 3.5MM AGGRESSIVE PLUS BLADE DEVICE BEFORE USE ON A PATIENT. 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 12745436 ↗
• InjuryDec 3, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ARTHROSCOPY THERE WERE METAL DEPOSITS IN THE JOINT BY ACTIVATING AN AGGRESSIVE BLADE PLUS. THEY WASHED THE JOINT TO REMOVE FRAGMENTS AND COMPLETE PROCEDURE WITH A DELAY OF 5 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10938774 ↗
• MalfunctionSep 30, 2019Suction Failure; Suction Failure

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING A KNEE ARTHROSCOPY WITH MENISCAL REPAIR THE 3.5 MM AGGRESSIVE PLUS 5PK DID NOT SUCTION, BLADE WAS FULL. PROCEDURE WAS COMPLETED, HOWEVER A SURGICAL DELAYED OF 5 MINUTES WAS REPORTED. NO PATIENT CONSEQUENCE WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9136699 ↗