NA DRIVERRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384001928), received between Jun 2, 2021 and Jun 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Vibration” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2021Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION PRE-TEST IT WAS DETERMINED THAT THE DRIVER DEVICE HAD VIBRATION. 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 2021. 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 11922974 ↗

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-1944-2017 · Oct 6, 2016 · Terminated
  XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
• Z-1995-2017 · Oct 6, 2016 · Terminated
  Keyless Driver Product Usage: Pneumatic system
• Z-1945-2017 · Oct 6, 2016 · Terminated
  XMAX Motor, High Strength Hose 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-0655-2014 · Apr 25, 2013 · Terminated
  ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
• 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-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-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-1897-2014 · Nov 28, 2012 · Terminated
  ANSPACH***Custom XMax Motor, Pneumatic***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.