FMS 283551Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886705016990), received between Apr 5, 2018 and Jul 30, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Output Problem” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K041824); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE REMOTE CONTROL(FMS VUE/NEXTRA DEVICE STOPPED WORKING. 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 22664554 ↗
• MalfunctionJun 9, 2025Output Problem; Physical Resistance/Sticking; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CHECK BLOOD STOP BUTTON ON THE REMOTE CONTROL (FMS VUE/NEXTRA) DEVICE STOPPED WORKING. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 22167821 ↗
• MalfunctionMar 11, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE REMOTE-CONTROL DEVICE CABLE WAS MISSING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE CONNECTOR CAP WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT. 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 21577115 ↗
• MalfunctionJan 23, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET UP, IT WAS DISCOVERED THAT THE REMOTE CONTROL (FMS VUE/NEXTRA) DEVICE WAS FUNCTIONING INTERMITTENTLY. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 21218257 ↗
• MalfunctionJan 15, 2025Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE STOPPED WORKING. 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 21158965 ↗
• MalfunctionSep 13, 2024Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED THAT THE REMOTE CONTROL (FMS VUE/NEXTRA) DEVICE MALFUNCTIONED/STOPPED WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 20213227 ↗
• MalfunctionJun 12, 2024Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING SET UP FOR AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, THE REMOTE CONTROL(FMS VUE/NEXTRA) DEVICE X2 WOULD NOT ROTATE OR OSCILLATE AND MADE A BEEPING NOISE ALONG WITH A SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE REMOTE CONTROL(FMS VUE/NEXTRA) DEVICE RUN/STOP BUTTON ACTIVATED WITHOUT FULLY PRESSING THE BUTTON, ONLY THE SHAVER SUCTION ¿-¿ AND SPEED ¿-¿ BUTTONS WORKED, THE REST OF THE BUTTONS DIDN¿T WORK AS INTENDED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19517776 ↗
• MalfunctionAug 17, 2023Output Problem; Output Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE REMOTE CONTROL DEVICE STOPPED RESPONDING. 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 17566067 ↗
• MalfunctionOct 13, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2020, IT WAS OBSERVED THAT THE REMOTE CONTROL DEVICE WAS DAMAGED; AND ITS CAP ON THE CORD TO PLUG INTO THE CONSOLE FELL OFF. 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 15598773 ↗
• MalfunctionJun 27, 2022Output Problem; Output Problem

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE REMOTE CONTROL DEVICE STOPPED WORKING. 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 14830120 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CAP ON THE REMOTE CONTROL FOR THE FLUID MANAGEMENT SYSTEM BROKE OFF; AND THEREFORE, COULD NOT BE STERILIZED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507354 ↗
• MalfunctionJan 15, 2021Physical Resistance/Sticking

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON 11/18/2020, IT WAS OBSERVED THAT THE BLOOD STOP BUTTON ON THE REMOTE CONTROL DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BUTTONS FOR PARAMETERS OF RUN/STOP, PRESSURE, SUCTION, FLOW, SPEED AND BLOOD STOP WERE WORKING INTERMITTENTLY AND DEFECTIVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11177972 ↗
• MalfunctionJan 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON 11/18/2020, IT WAS OBSERVED THAT THE BLOOD STOP BUTTON ON THE REMOTE CONTROL DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BUTTONS FOR PARAMETERS OF RUN/STOP, PRESSURE, SUCTION, FLOW, SPEED AND BLOOD STOP WERE WORKING INTERMITTENTLY AND DEFECTIVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11163804 ↗
• MalfunctionDec 4, 2020Output Problem; Physical Resistance/Sticking; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL VIA PHONE THAT DURING SET UP THE BUTTON TO INCREASE THE PRESSURE OF THE REMOTE CONTROL WAS NOT WORKING AND ALSO THE RUN/ STOP BUTTON WAS WORKING INTERMITTENTLY. NO PROCEDURE OR PATIENT INVOLVEMENT. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945396 ↗
• MalfunctionOct 16, 2020Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL VIA EMAIL THAT THE REMOTE CONTROL IS NOT WORKING. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. THE CUSTOMER DID NOT HAVE ADDITIONAL INFORMATION TO PROVIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693572 ↗
• MalfunctionSep 30, 2020Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE REMOTE CONTROLS FAILED. THE CIRCULATING NURSE MANUALLY ADJUSTED THE PRESSURE ON THE PUMP AS NEEDED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES, OR SURGICAL DELAY REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10607220 ↗
• MalfunctionSep 3, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING THE STERILIZATION PROCESS FLUID WAS LEAKING OUT OF THE REMOTE CONTROL. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487749 ↗
• MalfunctionJan 28, 2019Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER THAT THE CUSTOMER'S REMOTE CONTROL WAS WORKING INTERMITTENTLY CAUSING THE PUMP TO GO ON AND OFF BY ITSELF. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281706 ↗
• MalfunctionApr 5, 2018Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S FMS VUE REMOTE CONTROL STOPPED WORKING DURING A SHOULDER SCOPE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041824. One submission often covers many models, so check the product and lot details in each record.

• Z-0656-2016 · Nov 20, 2015 · Terminated
  FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0657-2016 · Nov 20, 2015 · Terminated
  FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.