Motor, Drill, Electric
Neurology · 21 CFR 882.4360
Recent MDR events
28,221 adverse event reports on file
- 8CM ANGLE ATTACHMENTJul 20, 2026MalfunctionDepuy Synthes Products Llc1045834-2026-00153
- MIDAS REX MR8Jul 18, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-05167
- 11 CM MEDIUM,QD ANGLE ATTACHMENTJul 17, 2026MalfunctionDepuy Synthes Products Llc1045834-2026-00152
- 11 CM MEDIUM,QD ANGLE ATTACHMENTJul 8, 2026MalfunctionDepuy Synthes Products Llc1045834-2026-00146
- NSKJul 7, 2026InjuryNakanishi Inc.9611253-2026-00029
- NSKJul 7, 2026InjuryNakanishi Inc.9611253-2026-00032
- MIDAS REX MR8Jul 2, 2026MalfunctionMdt Powered Surgical Solutions1625507-2026-04069
- 5 CM SHORT ATTACHMENTJun 24, 2026MalfunctionDepuy Synthes Products Llc1045834-2026-00141
- NSKJun 24, 2026InjuryNakanishi Inc.9611253-2026-00028
- 8CM MEDIUM ATTACHJun 23, 2026MalfunctionDepuy Synthes Products Llc1045834-2026-00139
Event type breakdown
Recalls
39 recall events for this product code
- The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems.
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0916-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax,
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0917-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
Adult Craniotome
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0918-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0919-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0920-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
Adult Craniotome, Large
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0921-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0922-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0923-2023 · View FDA record ↗ - The Anspach Effort, Inc.Open, ClassifiedJan 7, 2023
Pediatric Craniotome
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Z-0924-2023 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedFeb 2, 2015
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
Customer complaint indicating the color bands on the MIA16-G1 were not correct.
Z-1037-2015 · View FDA record ↗
Registered firms
108 firms currently registered for this product code
Medtronic Powered Surgical Solutions
FORT WORTH, TX, US
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Sterigenics Us Llc
Fort Worth, TX, US
Consolidated Medical Equipment Company
Chihuahua, MX
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Sterigenics U.s., Llc
Charlotte, NC, US
3d Medical Manufacturing, Inc. (dba Tecomet)
Riviera Beach, FL, US
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Nico Corporation
Indianapolis, IN, US
Nouvag Ag
GOLDACH Sankt Gallen, CH
Zethon Ltd
ASTON CLINTON Buckinghamshire, GB
Medtronic Puerto Rico Operations Co., Humacao
HUMACAO, PR, US
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Aesculap, Inc.
CENTER VALLEY, PA, US
Primo Medical Group, Inc
STOUGHTON, MA, US
Nouvatec, Llc
Walnut Spgs, TX, US
Synthes Gmbh
Zuchwil Solothurn, CH
Primo Medical Group, Inc
W Bridgewater, MA, US
510(k) clearances
26 clearances for this product code
- Saeshin Precision Co., Ltd.Sep 20, 2024
K233153 · Traus SSG10 Surgical System
- Saeshin Precision Co., Ltd.Sep 16, 2024
K232938 · Traus SSG30 Surgical System
- Bien-Air Surgery SAOct 31, 2022
K213697 · ORiGO System
- The Anspach Effort, Inc.May 19, 2022
K220485 · Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
- Zethon, Ltd.Apr 9, 2021
K193630 · hekaDrill
- Medtronic Powered Surgical SolutionsMay 12, 2019
K183515 · MR8 Drill System, Midas Rex MR8 ClearView Tools
- Bien-Air Surgery SAJun 22, 2018
K173066 · OSSEODUO Shaver and Drill System
- Medtronic Powered Surgical SolutionsMay 15, 2017
K170312 · IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools