FMSRecalls & reported problems across all models

We found 9 models of FMS by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 434 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2017 and May 20, 2024 — classified as 2 injuries, 432 malfunctions.

The most frequently reported specific device problem is “Corroded” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FMS problems

FMS models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FMS 288022

  ARTHROSCOPE
  296 reports
• FMS 284504

  ARTHROSCOPE
  81 reports
• FMS 284176

  ARTHROSCOPE
  33 reports
• FMS 218019

  ACCESSORIES,ARTHROSCOPIC
  7 reports
• FMS 282112

  ARTHROSCOPE
  5 reports
• FMS 284172

  ARTHROSCOPE
  4 reports
• FMS 218023

  ACCESSORIES,ARTHROSCOPIC
  4 reports
• FMS 287869

  ARTHROSCOPE
  2 reports
• FMS 218021

  ACCESSORIES,ARTHROSCOPIC
  2 reports

Recent FMS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE SCOPE PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS CAUSING THE PUMP TO READ HIGH PRESSURE AND THE DEVICE HAD BAD TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352379 ↗
• MalfunctionMay 20, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING KNEE SCOPE PROCEDURE ON (B)(6) 2024 THE IRRIGATION TUBESET DEVICE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS CAUSING THE PUMP TO READ HIGH PRESSURE AND HAD BAD TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352295 ↗
• MalfunctionMay 20, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS CAUSING THE PUMP TO READ HIGH PRESSURE AND THE DEVICE HAD BAD TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351324 ↗
• MalfunctionApr 25, 2024Use of Device Problem; Blocked Connection; Suction Failure; Use of Device Problem; Blocked Connection; Suction Failure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE FMS CONNECT (DUO/SOLO) DEVICE CABLE NOT SYNCHING WITH SHAVER; TRIED A DIFFERENT SHAVER AND CABLE STILL NOT WORKING. SWAPPED CABLE. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A SUCTION FAILURE. 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 19179977 ↗
• MalfunctionApr 24, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON 3/10/2024 IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE CHAMBERS OVERFILLED AND WATER WENT TO THE SENSOR VALVE ON TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171308 ↗
• MalfunctionMar 13, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) HAD THE PUMP FILL CHAMBER KEPT FILLING UP AND SHUTTING THE PUMP THEN GOING TO LOW PRESSURE MODE. THEY CHANGED THE PUMP WITH NO RESOLUTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH A COUPLE OF MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896302 ↗
• MalfunctionMar 6, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS DUO+ OR FMS SOLO) HAD THE PUMP FILL CHAMBER KEPT FILLING UP AND SHUTTING THE PUMP THEN GOING TO LOW PRESSURE MODE. THEY CHANGED THE PUMP WITH NO RESOLUTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH A COUPLE OF MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849511 ↗
• MalfunctionMar 6, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) HAD THE PUMP FILL CHAMBER KEPT FILLING UP AND SHUTTING THE PUMP THEN GOING TO LOW PRESSURE MODE. THEY CHANGED THE PUMP WITH NO RESOLUTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH A COUPLE OF MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849505 ↗
• MalfunctionJan 25, 2024Overfill; Overfill

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE CHAMBER ON THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE FILLED UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE 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 18579834 ↗
• MalfunctionDec 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN PROCEDURE ON 11/22/2023, IT WAS OBSERVED THAT THE HAND PC TORNADO SHAVER DEVICE WAS HOT DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE 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 18301216 ↗
• MalfunctionDec 7, 2023Device Remains Activated; Output Problem; Unintended Movement; Device Remains Activated; Output Problem; Unintended Movement

  IT WAS REPORTED BY SALES REP THAT ON 10/13/2023, IT WAS OBSERVED THAT TWO (2) FMS CONNECT INTERFACE CABLE DUO/SOLO WERE HAVING ISSUES. ONE INTERFACE CABLE WOULD CONTINUE TO RUN EVEN WHEN NOT ACTIVATED AND THE OTHER ONE SEEMED LOOSE ON THE BACK OF THE HANDPIECE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION. THE ISSUE WAS FOUND OUTSIDE OF THE PROCEDURE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282766 ↗
• MalfunctionNov 8, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, WHILE USING AN FMS DUO PUMP DEVICE, THE SALINE CHAMBER FILLED ALL WAY UP TWO DIFFERENT SETS OF INFLOW TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094239 ↗
• MalfunctionNov 8, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, WHILE USING AN FMS DUO PUMP DEVICE, THE SALINE CHAMBER FILLED ALL WAY UP TWO DIFFERENT SETS OF INFLOW TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093557 ↗
• MalfunctionNov 8, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, WHILE USING AN FMS DUO PUMP DEVICE, THE SALINE CHAMBER FILLED ALL WAY UP TWO DIFFERENT SETS OF INFLOW TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093492 ↗
• MalfunctionOct 25, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE AFFILIATE IN SWEDEN THAT DURING THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 4172 FOOT PED BOARD 2WAY DEVICE HAD INCORRECT LABELING. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003649 ↗

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