FMS 283719Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705022076), received between Feb 1, 2019 and Feb 7, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE FEW METAL PARTS IN THE SHOULDER JOINT WHILE USING THE AGGRESIVE 5.0MM BLADE DEVICE. ACCORDING TO THE REPORTER, IT WAS UNKNOWN IF ALL FRAGMENTS WERE REMOVED FROM THE PATIENT'S BODY. THERE WAS NO PROCEDURE SCHEDULED TO REMOVE FRAGMENTS. 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 13472783 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WERE METALLIC DEBRIS WHILE THE BLADE DEVICE WAS BEING USED. THE DEBRIS WERE VACUUMED. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556002 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WERE METALLIC DEBRIS IN THE JOINT WHILE USING A 5 MM AGGRESSIVE BLADE PLUS DEVICE AS THEY STARTED USING THE SHAVER. THE METALLIC DEBRIS WERE ELIMINATED WITH SHAVER SUCTION. DEBRIS WAS PRESENT ONLY DURING THE 15 FIRST SECONDS OF SHAVER USAGE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506752 ↗
• MalfunctionMar 10, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WAS A RELEASE OF METALLIC DEPOSITS WHEN THE BLADE DEVICE WAS ACTIVATED IN THE FIRST THREE SECONDS. THE JOINT WAS CLEANED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455412 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THERE WERE A LOT OF METAL ABRASIONS DURING A 10,000 FORWARD WITH THE HANDPIECE DEVICE. THERE WAS A DELAY OF FIVE MINUTES IN THE PROCEDURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE FRAGMENTS WERE REMOVED EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10877260 ↗
• MalfunctionJun 3, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA CST TOOL THAT THE SHAVER TERMINAL CUTTER AGGRESSIVE 5.0 MM BLADE SPREAD METAL PARTICLES IN TO THE JOINT WHILE DOING THE SHOULDER ARTHROSCOPY. THE PROCEDURE WAS COMPLETED BY SWAPPING OUT FOR ANOTHER LIKE DEVICE WITH NO SURGICAL DELAY IN THE PROCEDURE. FRAGMENTS WERE GENERATED BUT WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WITH NO PATIENT CONSEQUENCES. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT THE PROBLEM HAS ONLY BEEN WITH THE ENGINE TERMINAL FMS VUE REF 283719 THAT RELEASED METAL PARTICLES, THE REST OF THE PRODUCTS WORKED PERFECTLY AND DID NOT GENERATE ANY TYPE OF FAILURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662306 ↗
• MalfunctionFeb 1, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE AFFILIATE VIA THE CST TOOL THAT DURING AN UNKNOWN PROCEDURE THE SHAVER PRODUCED METAL ABRASIONS AFTER STARTING IT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER, THERE WAS AN APPROXIMATE DELAY OF 10 MINUTES REPORTED. NO PATIENT HARM WAS REPORTED BY THE AFFILIATE. ADDITIONAL INFORMATION RECEIVED ON 01/10/2019 FROM THE AFFILIATE STATING THAT THERE WAS A SURGERY DELAY AROUND 10 MINUTES TO SUCTION OF METAL PARTS AND CHANGING SHAVER.

  Patient problems: Not Applicable

  MAUDE report 8298027 ↗