FMS 283712Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886705030736), received between Apr 5, 2022 and Sep 28, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Output Problem” (10 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  It was reported that during service and evaluation, it was determined that the SHAVER HANDPIECE 2.0 WITHOUT BUTTONS device had an electrical short. It was noted in the service order that the device displayed an FC05 and FC14 error code during a 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 50914965 ↗
• MalfunctionSep 17, 2026Overheating of Device; Use of Device Problem

  It was reported that during an unspecified arthroscopic procedure the SHAVER HANDPIECE 2.0 WITHOUT BUTTONS device became abnormal high temperature and stopped working.. 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 50803828 ↗
• MalfunctionAug 24, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416990 ↗
• MalfunctionApr 15, 2026Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE DEVICE WOULD NOT LOCK/UNLOCK. IT WAS REPORTED IN THE SERVICE ORDER THAT THE PLASTIC PIECE OF THE DEVICE WAS STUCK IN THE SHAVER DEVICE DURING HIP SURGERY. THERE WERE NO REPORTS OF DELAYS TO A 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 24885003 ↗
• MalfunctionApr 6, 2026Defective Alarm

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ALARM DID NOT TRIGGER ON THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS 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 24793888 ↗
• MalfunctionMar 24, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A ROUTINE ARTHROSCOPIC SURGERY, IT WAS DISCOVERED THAT THE HANDLE OF THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE OVERHEATED SEVERELY, RENDERING IT UNUSABLE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT 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 24674933 ↗
• MalfunctionMar 9, 2026Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE FELL APART. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS MISSING A SCREW AT THE TOP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A 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 24552275 ↗
• MalfunctionJan 21, 2026Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE FELL APART. IT WAS INITIALLY REPORTED THAT THE CUSTOMER RECEIVED A REPLACEMENT SHAVER HANDPIECE FROM FINISHED GOODS THAT EXHIBITED PHYSICAL DAMAGE UPON RECEIPT. THE EVENT WAS NOT RELATED TO 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 24132937 ↗
• MalfunctionNov 17, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ITEM SHAVER HANDPIECE DEVICE OVERHEATED DURING A ROTATOR CUFF REPAIR 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 23571581 ↗
• MalfunctionSep 12, 2025Overheating of Device; Output Problem; Overheating of Device; Output Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE BECAME HOT AND STOPPED WORKING. THERE WAS A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 23040267 ↗
• MalfunctionJul 30, 2025Break; Use of Device Problem; Detachment of Device or Device Component; Break; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE HAD BROKEN PIECES THAT CAME OFF THE TOP AND TWO SCREWS ON THE SIDE WERE MISSING. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662802 ↗
• MalfunctionMay 28, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE WOULD NOT WORK OR ROTATE PROPERLY. 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 22096208 ↗
• MalfunctionMay 5, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE WAS FOUND TO BE MISSING ITS LOCKING PIECE. ACCORDING TO THE REPORTER, THE SCREWS WERE MISSING SO IT FELL OFF AT THE END OF THE PROCEDURE. 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 21962254 ↗
• MalfunctionFeb 18, 2025Use of Device Problem; Infusion or Flow Problem; Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE THE SHAVER HAD NO SUCTION AND STOPPED WORKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. 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 21399899 ↗
• MalfunctionJan 28, 2025Overheating of Device; Output Problem; Overheating of Device; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE OVERHEATED AND STOPPED FUNCTIONING. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS 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 21255305 ↗
• MalfunctionJan 27, 2025Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECT WAS IDENTIFIED: HEAT. THERE WAS NO NOR PROCEDURE NOR PATIENT INVOLVEMENT 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 21246187 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT DURING POST-SURGERY PROCEDURE, IT WAS DISCOVERED THAT THE O-RING FROM THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE BROKE INTO TWO PIECES. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 20629174 ↗
• MalfunctionAug 27, 2024Break; Electrical /Electronic Property Problem; Scratched Material; Noise, Audible; Break; Electrical /Electronic Property Problem; Scratched Material; Noise, Audible

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN FMS FULL RADIUS BLADE PLUS 4.0MM DEVICE AND A SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, THE SHAVER MADE A RANDOM LOUD AND SCRATCHY SOUND LIKE "NAILS ON CHALKBOARD" THEN SHOT OUT METAL SHAVINGS EVERYWHERE IN THE JOINT. IT WAS FURTHER REPORTED THAT THE SHAVER HAD AN ERROR CODE FC014. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. 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 20076194 ↗
• MalfunctionAug 6, 2024Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED FROM THE SALES REP VIA PHONE THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE OVERHEATED AND ALSO DISPLAYED AN FC14 ERROR CODE. 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 19916363 ↗
• MalfunctionMay 17, 2024Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 4580 FMS DUO+ PUMP/SHAVER DEVICE SHAVER STOPPED OSCILLATING MID-CASE, THE USER DID NOT RECEIVE AN ERROR CODE. A SPARE DEVICE WAS USED TO COMPLETED THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 19345064 ↗
• MalfunctionApr 1, 2024Use of Device Problem; Infusion or Flow Problem; Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED FROM SWITZERLAND THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE DID NOT WORK WHEN PLUGGED IN AS IT HAD NO SUCTION. THERE WAS A DELAY OF THREE MINUTES IN THE SURGICAL PROCEDURE AND A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19011880 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SHOULDER SURGICAL PROCEDURE ON AN UNKNOWN DATE THE SHAVER HANDPIECE DEVICE BLADE HAD NOTICEABLE METAL SHAVINGS WHILE IN USE WITH THE FULL RADIUS DEVICE. 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. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980374 ↗
• MalfunctionMar 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE WAS INSERTED IT DID NOT FULLY CONNECT. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ANOTHER LIKE DEVICE WAS USED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934493 ↗
• MalfunctionJan 18, 2024Overheating of Device; Output Problem; Overheating of Device; Output Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2024 THE SHAVER HANDPIECE DEVICE GOT HOT THEN STOPPED WORKING MID CASE. THERE WAS A TEN 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 18535901 ↗
• MalfunctionOct 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM THE SALES REP THAT THE SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE SILVER DIAL THAT ROTATES TO ACCEPT A BLADE/BURR FELL OF THE HANDPIECE. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028542 ↗

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-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-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-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