NA XMAXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,225 adverse event reports that list this exact device (DI 00845384010791), received between Dec 7, 2017 and Sep 30, 2026 — classified as 6 injuries, 1,219 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (453 reports).

11 other recalls cover devices cleared under the same FDA submission (K965080); 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 1,225 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Complete Loss of Power; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947001 ↗
• MalfunctionSep 17, 2026Noise, Audible; Excessive Heating

  It was reported that the motor device produced noise and overheated. It was not reported if the device was used in surgery. It was not reported if there were any delays in a surgical procedure or if a spare device was available. 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 50803048 ↗
• MalfunctionAug 4, 2026Break; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the xmax device hoe ruptured. It was noted in the service order that the device did not function. 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 2026.All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129089 ↗
• MalfunctionJul 27, 2026Leak/Splash; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50042490 ↗
• MalfunctionFeb 27, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE VELYS SATELLITE STATION DEVICE AND THE VELYS BASE STATION DEVICE, DURING THE TIBIAL CUT, THE ROBOT ARM SUDDENLY JUMPED ABOUT 2¿3 MM DISTALLY. EVEN AFTER RESETTING TO THE HOME POSITION, THE SYSTEM PROCEEDED WITH A CHANGED PLANNED CUT. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475285 ↗
• MalfunctionFeb 10, 2026Improper or Incorrect Procedure or Method; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, AN ANTERIOR CHAMFER CUT WAS OFF BY MULTIPLE MILLIMETERS AND THE SAW KEEPS STUTTERING WHILE USING THE VELYS SATELLITE STATION DEVICE. THE DEVICE WAS IN USE WITH THE VELYS BASE STATION DEVICE AND THE VELYS SAW HANDPIECE DEVICE. THE ROBOT WAS NOT MOUNTED TO THE BED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Bone Notching; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303406 ↗
• MalfunctionJan 9, 2026Leak/Splash; Material Rupture; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD A HOSE RUPTURE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE MOTOR WAS NOT RUNNING. IT SEEMED THAT THE AIR WAS REACHING PARTWAY TO THE MOTOR. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020637 ↗
• MalfunctionNov 26, 2025Complete Loss of Power; Fail-Safe Did Not Operate; Complete Loss of Power; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE HAD HOSE DAMAGE, RUN IN THE LOCKED POSITION AND HAD INSUFFICIENT/LOW POWER. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT, HOSE ASSESSMENT, SAFETY ASSESSMENT, ROTATIONAL SPEED ASSESSMENT AND OIL LEAK ASSESSMENT. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT FUNCTION. 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. THE DATE OF EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656760 ↗
• MalfunctionOct 16, 2025Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE WAS LEAKING AIR, HAD COSMETIC DAMAGE, HAD HOSE DAMAGE (EXCLUDING RUPTURE), INSUFFICIENT/LOW POWER AND MADE EXCESSIVE NOISE. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT, HOSE ASSESSMENT, MUFFLER TUBE ASSESSMENT, NOISE ASSESSMENT AND ROTATIONAL SPEED ASSESSMENT. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD A HOLE IN THE HOSE DURING AN UNSPECIFIED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310622 ↗
• MalfunctionSep 16, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE MOTOR DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE RAN IN A LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR SAFETY ASSESSMENT: DEVICE DOES NOT OPERATE WITH SAFETY ENGAGED. IT WAS NOTED THAT THE DEVICE RAN ON LOCK MODE AND HAD WORN OFF PAWL RELEASE. 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 23060907 ↗
• MalfunctionAug 26, 2025Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE MOTOR DEVICE DID NOT WORK PROPERLY. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HOSE WAS DAMAGED (EXCLUDING RUPTURE), MADE EXCESSIVE NOISE AND WAS LEAKING AIR. THE DEVICE ALSO FAILED PRETESTS FOR HOSE ASSESSMENT AND NOISE ASSESSMENT. 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 22894108 ↗
• MalfunctionJul 3, 2025Complete Loss of Power; Fail-Safe Did Not Operate; Complete Loss of Power; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE MOTOR DEVICE DID NOT FUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD COMPONENT DAMAGE, HOSE DAMAGE, INSUFFICIENT/LOW POWER AND THE DEVICE RAN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, HOSE, SAFETY AND ROTATIONAL SPEED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395040 ↗
• MalfunctionJun 20, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE MOTOR DEVICE KEPT RELEASING THE CUTTER DEVICE DURING SURGERY. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HOSE WAS DAMAGED, WAS LEAKING A LIQUID, WAS MISSING COMPONENTS AND HAD INSUFFICIENT/LOW POWER. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT, HOSE ASSESSMENT, MUFFLER TUBE ASSESSMENT, ROTATIONAL SPEED ASSESSMENT AND OIL LEAK ASSESSMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302347 ↗
• MalfunctionJun 20, 2025Break; Complete Loss of Power; Fail-Safe Did Not Operate; Break; Complete Loss of Power; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE MOTOR DEVICE HAD A HOLE IN THE TUBING AND WOULD NOT DRILL. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE RUNS IN THE LOCKED POSITION. THE DEVICE ALSO FAILED PRETESTS FOR SAFETY ASSESSMENT. 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 22302185 ↗
• MalfunctionJun 16, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE MOTOR DEVICE STOPPED SUDDENLY DURING OPERATION. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN A PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. 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 22214086 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR DEVICE WAS LEAKING OIL. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187140 ↗
• MalfunctionMay 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MOTOR DEVICE WAS LEAKING AIR. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD HOSE DAMAGE, THE MOVING PARTS DID NOT MOVE SMOOTHLY, WAS LEAKING A LIQUID AND WAS LEAKING AIR. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT, HOSE ASSESSMENT AND MOTOR RUB ASSESSMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979395 ↗
• MalfunctionApr 23, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD INSUFFICIENT/LOW POWER, THE HOSE WAS DAMAGED, THE DEVICE RUNS IN THE LOCKED POSITION, WAS LEAKING A LIQUID, MADE EXCESSIVE NOISE AND THE MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR VISUAL ASSESSMENT, HOSE ASSESSMENT, MOTOR RUB ASSESSMENT, SAFETY ASSESSMENT, NOISE ASSESSMENTS, ROTATIONAL SPEED ASSESSMENT AND OIL LEAK ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS LEAKING AIR. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893666 ↗
• MalfunctionApr 2, 2025Leak/Splash; Output below Specifications; Leak/Splash; Output below Specifications

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE WAS LOOSE, LEAKING LIQUID, HAD INSUFFICIENT/LOW POWER, AND THE HOSE WAS DAMAGED. IT WAS NOTED THAT THE HOSE HAD SCRATCHES, THE HOUSING PIN WAS LOOSE, INSUFFICIENT ROTATION SPEED, AND OIL LEAKED FROM THE SWIVEL. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, HOSE ASSESSMENT, LOCTITE ASSESSMENT, ROTATIONAL SPEED ASSESSMENT, AND OIL LEAK ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD LOW POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2025. 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 21751648 ↗
• MalfunctionMar 24, 2025Break; Complete Loss of Power; Break; Complete Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE RUBBER HOSES HAD A HOLE/BUSTED DURING USE. THERE WAS NO PATIENT INJURY, NO DELAY IN THE CASE, AND A BACKUP DEVICE WAS AVAILABLE TO FINISH EACH OF THE CASES IN WHICH THE HOLES WERE DISCOVERED. THERE WAS PATIENT INVOLVEMENT. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678550 ↗
• MalfunctionMar 24, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE RUBBER HOSE HAD A HOLE IN IT. IT WAS FURTHER REPORTED THAT THE DEVICE HAD A BROKEN TIP METAL SHADE INSIDE THE TIP. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675929 ↗
• MalfunctionJan 29, 2025Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT THE MOTOR DEVICE MADE AN UNUSUAL NOISE AND THERE MAY BE A HOLE IN THE HOSE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE PRODUCED EXCESSIVE NOISE, INSUFFICIENT/LOW POWER AND HAD COSMETIC DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, NOISE ASSESSMENT AND ROTATIONAL SPEED ASSESSMENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A 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 21265290 ↗
• MalfunctionJan 21, 2025Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MOTOR DEVICE WAS LEAKING OIL. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF A DELAY IN THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21199528 ↗
• MalfunctionJan 10, 2025Leak/Splash; Device Slipped; Device Markings/Labelling Problem; Leak/Splash; Device Slipped; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD A LIQUID LEAK. IT WAS DETERMINED THAT THE DEVICE HAD COSMETIC DAMAGE AND WAS LOOSE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, MUFFLER TUBE ASSESSMENT, LOCTITE ASSESSMENTS AND OIL LEAK ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE CONNECTION TO THE PERFORATOR DRIVER DEVICE WAS LOOSE, AND THE MOTOR DEVICE HAD LABEL DAMAGE. THE REPORTER CONFIRMED THAT THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE PERFORATOR DRIVER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125881 ↗
• MalfunctionJan 10, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE HAD A HOLE IN THE HOSE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HOSE WAS DAMAGED AND WAS LEAKING A LIQUID. THE DEVICE ALSO FAILED PRETESTS FOR HOSE ASSESSMENT AND OIL LEAK ASSESSMENT. IT WAS NOT REPORTED IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124251 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K965080. One submission often covers many models, so check the product and lot details in each record.

• Z-1945-2017 · Oct 6, 2016 · Terminated
  XMAX Motor, High Strength Hose Product Usage: Pneumatic system
• Z-1995-2017 · Oct 6, 2016 · Terminated
  Keyless Driver Product Usage: Pneumatic system
• Z-1944-2017 · Oct 6, 2016 · Terminated
  XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
• Z-0779-2014 · May 6, 2013 · Terminated
  Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and crani
• Z-0656-2014 · Apr 25, 2013 · Terminated
  ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
• Z-0655-2014 · Apr 25, 2013 · Terminated
  ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
• Z-1897-2014 · Nov 28, 2012 · Terminated
  ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
• Z-1894-2014 · Nov 28, 2012 · Terminated
  ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
• Z-1898-2014 · Nov 28, 2012 · Terminated
  ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
• Z-1008-2007 · May 18, 2007 · Terminated
  Anspach Single Use, Sterile Bone Cutting Burrs
• Z-1039-2008 · Dec 18, 2006 · Terminated
  Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.