Motor, Drill, Electric

Device Code: 3703

Product Code(s): HBC

Device Classification Information

• Device Type ID: 3703
• Device Name: Motor, Drill, Electric
• Regulation Description: Electric Cranial Drill Motor.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
• Submission Type: 510(k)
• CFR Regulation Number: 882.4360 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HBC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3703
• Device: Motor, Drill, Electric
• Product Code: HBC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Electric Cranial Drill Motor.
• CFR Regulation Number: 882.4360 [🔎]

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIEN-AIR SURGERY SA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Overheating Of Device	2327
Vibration	658
Unintended System Motion	386
Bent	302
Fail-Safe Problem	270
Device Displays Incorrect Message	232
Detachment Of Device Component	223
Material Twisted / Bent	201
Device Inoperable	196
Device Operates Differently Than Expected	184
Detachment Of Device Or Device Component	136
Break	122
Fracture	90
Noise, Audible	87
Tip	74
Mechanical Problem	60
Difficult To Position	55
Bearings	39
Temperature Problem	38
Difficult To Remove	35
Difficult To Insert	34
Naturally Worn	33
Fluid Leak	30
Material Separation	30
Smoking	29
Device Stops Intermittently	28
Defective Component	26
Cable	26
Device Operational Issue	25
Wire	25
Defective Device	23
Material Deformation	22
Mechanical Jam	21
Handpiece	21
Cord	20
Motor	19
Loose Or Intermittent Connection	19
Cut In Material	17
Component Missing	15
Cutter	15
Hose	14
Output Below Specifications	14
Fitting Problem	12
Loss Of Power	12
Sticking	11
Material Rupture	10
Device Alarm System	10
Failure To Power Up	9
Plate	8
Positioning Problem	8
Device Slipped	8
Torn Material	7
Crack	7
Moisture Damage	7
Corroded	7
Lock	6
Connection Problem	6
Component Falling	6
Device Damaged By Another Device	6
Image Display Error / Artifact	6
Leak / Splash	5
Excessive Heating	5
Air Leak	5
Hole In Material	5
Thermal Decomposition Of Device	5
Gears	5
Adverse Event Without Identified Device Or Use Problem	5
Material Integrity Problem	5
Power Problem	4
Pin	4
Shaft	4
Electrical /Electronic Property Problem	4
Material Frayed	4
Contamination / Decontamination Problem	4
Metal Shedding Debris	4
Dull, Blunt	4
Unintended Movement	4
Device Contaminated During Manufacture Or Shipping	3
Material Fragmentation	3
Locking Mechanism	3
Housing	3
Connector	3
Premature Activation	3
Degraded	3
Contamination During Use	3
Unstable	2
Foot Switch	2
Appropriate Term/Code Not Available	2
Self-Activation Or Keying	2
Controller	2
No Fail-Safe Mechanism	2
Disconnection	2
Moisture Or Humidity Problem	2
Device Markings / Labelling Problem	2
Material Distortion	1
Mechanics Altered	1
Malposition Of Device	1
Erratic Or Intermittent Display	1
Entrapment Of Device	1
Wiring Harness	1
Total Device Problems	6491

Recalls
Manufacturer		Recall Class	Date Posted
1	The Anspach Effort, Inc.	II	May-04-2017
2	The Anspach Effort, Inc.	II	Jul-21-2016
3	The Anspach Effort, Inc.	II	Feb-02-2015
4	The Anspach Effort, Inc.	II	Jun-25-2014
5	The Anspach Effort, Inc.	II	Jan-27-2014

TPLC Last Update: 2019-04-02 20:35:02