FMS 283812Recalls & reported problems

Summary

The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 10886705030743), received between Apr 9, 2021 and Sep 17, 2026 — classified as 374 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (109 reports).

4 other recalls cover devices cleared under the same FDA submission (K041824, K954465); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 374 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Overheating of Device

  It was reported that during Arthroscopic Rotator Cuff Repair surgery, while removing a subacromial osteophyte the SHAVER HANDPIECE 2.0 WITH BUTTONS used with the round burr plus 4.0mm produced a weaker-than-usual rotational sound and then rapidly became hot. The handpiece became too hot for the surgeon to hold. It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery. 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 50802034 ↗
• MalfunctionSep 15, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779595 ↗
• MalfunctionSep 15, 2026Use of Device Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779348 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776289 ↗
• MalfunctionAug 20, 2026Mechanical Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355345 ↗
• MalfunctionAug 11, 2026Electrical Shorting; Mechanical Jam; Output Problem

  It was reported that the SHAVER HANDPIECE 2.0 WITH BUTTONS device locked up after a few seconds of running. It was not reported if the event occurred during a surgical procedure. It was reported that another shaver was used to complete the procedure. During in-house engineering evaluation it was determined that the device had an electrical short. There was no surgical delay or patient harm. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209289 ↗
• MalfunctionMay 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE FAILED TO HOLD THE SHAVER BLADE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TWO MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241918 ↗
• MalfunctionApr 30, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE DEVICE HAD DEBRIS PRESENT INSIDE THE DEVICE. 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 25045859 ↗
• MalfunctionApr 30, 2026Electrical Shorting

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE HAD AN ELECTRICAL SHORT. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25044764 ↗
• MalfunctionApr 29, 2026Electrical Shorting; Mechanics Altered

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE HAD AN ELECTRICAL SHORT. IT WAS NOTED BY THE REPORTER THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR WAS DEFECTIVE. THERE WAS FIFTEEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 25034689 ↗
• MalfunctionApr 28, 2026Device Remains Activated

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE BLOOD-STOP ACTIVATED WITHOUT PRESSING ANY BUTTONS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021171 ↗
• MalfunctionApr 28, 2026Overheating of Device; Output Problem

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, THE FMS ARTHROSCOPE STOPPED OPERATING AFTER 3 OR 4 SECONDS WHEN AN ERROR CODE APPEARED, ACCOMPANIED BY EXCESSIVE HEAT ON THE HANDPIECE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013951 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FMS SCREWS CAME OUT OF THE UPPER LOCKING MECHANISM DURING A CASE AND THE SHAVER WAS IN TWO PIECES. THEY SWAPPED OUT THE SHAVER AND CONTINUED WITH CASE WITH NO NEGATIVE IMPACT TO THE PATIENT OR THE CASE. THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013767 ↗
• MalfunctionApr 9, 2026Use of Device Problem; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE FELL APART. IT WAS INITIALLY REPORTED THAT THE SHAVER HANDPIECE WAS BROKEN. A SMALL SCREW BECAME DISLODGED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT FUNCTIONING DUE TO THE FAULTY SCREW. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833883 ↗
• MalfunctionApr 1, 2026Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SCOPING SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE WAS GETTING VERY HOT. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754086 ↗
• MalfunctionMar 30, 2026Overheating of Device

  IT WAS REPORTED THAT THE FMS ARTHROSCOPE WAS GETTING HOT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. 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 24730161 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property Problem; Output Problem; Noise, Audible

  IT WAS REPORTED THAT HALFWAY THROUGH AN UNSPECIFIED PROCEDURE WHEN THE FMS SHAVER WAS TURNED ON, IT MADE A LOUD IRREGULAR NOISE. IT WAS AS IF THE MOTOR SHORTED OUT. THE CASE WAS SUCCESSFULLY COMPLETED BY GETTING ANOTHER SHAVER HANDPIECE. THERE WAS NO PATIENT HARM OR DELAY. THE DEVICE IS AVAILABLE FOR RETURN AND REPAIR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725943 ↗
• MalfunctionMar 20, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE HEATED UP. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE DISPLAYED A FC005 ERROR CODE DURING AN UNSPECIFIED SURGICAL PROCEDURE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. 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 24649730 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component; Output Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE WOULD NOT LOCK/UNLOCK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN ERROR CODE DURING A SCOPE PROCEDURE IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE TO COMPLETED THE PROCEDURE WITH NO SURGICAL DELAY. 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 24598473 ↗
• MalfunctionMar 13, 2026Output Problem; Noise, Audible

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE WOULD NOT ROTATE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE MADE A LOUD RATTLING NOISE LIKE IT WAS STRUGGLING BEFORE IT STOPPED WORKING COMPLETELY. 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 24592516 ↗
• MalfunctionMar 12, 2026Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE WAS HEATING UP WHILE USING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581328 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE WOULD NOT LOCK/UNLOCK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS BROKEN DURING A SCOPE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6). ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561087 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS HAD A BROKEN CAP. THERE WAS NO PATIENT INVOLVEMENT? THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO FURTHER INFORMATION REGARDING THE ISSUE WAS PROVIDED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504854 ↗
• MalfunctionFeb 19, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE WAS MAKING A GRINDING NOISE AND GETTING HOT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. 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 24389786 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE SCREWS ON THE SHAVER HANDPIECE 2.0 WITH BUTTONS, LOCATED JUST BELOW THE BLADE LOCKRING, FELL OUT OF THE HANDPIECE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR 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 24337897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041824, K954465. 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.
• Z-0658-2016 · Nov 20, 2015 · Terminated
  FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0192-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the ar