TPLC - Total Product Life Cycle

• Device: drills, burrs, trephines & accessories (simple, powered)
• Regulation Description: Powered simple cranial drills, burrs, trephines, and their accessories.
• Product Code: HBE
• Regulation Number: 882.4310
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADEOR MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
AD-TECH
	SUBSTANTIALLY EQUIVALENT	1
AD-TECH MEDICAL INSTRUMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOTEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MRI INTERVENTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Overheating of Device	1116
Flaked	621
Break	465
Fracture	172
Disassembly	94
Bent	82
Vibration	60
Detachment of Device or device Component	47
Device Operates Differently Than Expected	28
Device Inoperable	25
Mechanical Problem	24
Material Twisted / Bent	22
Noise, Audible	21
Detachment Of Device Component	20
Material Fragmentation	16
Fluid Leak	14
Leak / Splash	12
Device Displays Incorrect Message	12
Sticking	11
Material Separation	9
Temperature Problem	9
Smoking	8
Difficult to Remove	8
Device Remains Activated	7
Packaging Problem	7
Difficult To Position	6
Self-Activation or Keying	6
Tip	6
Cutter	6
Defective Component	5
Bearings	5
Connection Problem	5
Unintended System Motion	5
Adverse Event Without Identified Device or Use Problem	4
Shaft	4
Use of Device Problem	4
Metal Shedding Debris	4
Material Deformation	4
Mechanical Jam	3
Difficult to Insert	3
Dull, Blunt	3
Material Integrity Problem	3
Unstable	3
Material Disintegration	3
Failure To Adhere Or Bond	2
Component Missing	2
No Apparent Adverse Event	2
Unintended power up	2
Delivered as Unsterile Product	2
Output below Specifications	2
Loose or Intermittent Connection	2
Insufficient Information	2
Unintended Movement	2
Peeled / Delaminated	2
Inadequacy of Device Shape and/or Size	1
Fitting Problem	1
Cover	1
Guide	1
Partial Blockage	1
Device Subassembly	1
Excessive Heating	1
Locking Mechanism	1
Tube	1
Material Protrusion / Extrusion	1
Device Emits Odor	1
Failure to Power Up	1
Naturally Worn	1
Gears	1
Charred	1
Ambient Noise Problem	1
Biocompatibility	1
Device Markings / Labelling Problem	1
Positioning Problem	1
Device Alarm System	1
Thermal Decomposition of Device	1
Component Falling	1
Computer Software Problem	1
Ventilation Problem in Device Environment	1
Misfire	1
Fail-Safe Problem	1
Contamination / decontamination Problem	1
Deformation Due to Compressive Stress	1
Material Discolored	1
Misconnection	1
Device Stops Intermittently	1
Handpiece	1
Total Device Problems	3044

Recalls
Manufacturer		Recall Class	Date Posted
1	Ad-Tech Medical Instrument Corporation	II	Jul-25-2018
2	Aesculap Implant Systems LLC	II	Feb-15-2018
3	EXP Pharmaceutical Services Corp	II	Jul-24-2015
4	Medtronic Sofamor Danek Usa, Inc - Dallas Distribution	II	Jun-28-2016
5	Stryker Instruments Div. of Stryker Corporation	II	Dec-21-2016
6	Stryker Instruments Div. of Stryker Corporation	II	Jul-19-2016
7	Stryker Instruments Div. of Stryker Corporation	II	Jul-14-2016
8	Stryker Instruments Div. of Stryker Corporation	II	Jun-11-2014
9	The Anspach Effort, Inc.	II	May-04-2017
10	The Anspach Effort, Inc.	II	Sep-16-2016
11	The Anspach Effort, Inc.	II	Jul-29-2015
12	The Anspach Effort, Inc.	II	Jun-25-2014
13	The Anspach Effort, Inc.	II	Jan-15-2014
14	The Anspach Effort, Inc.	II	Jan-13-2014
15	The Anspach Effort, Inc.	II	Jan-10-2014
16	The Anspach Effort, Inc.	II	Jan-09-2014