TPLC - Total Product Life Cycle

• Device: motor, drill, electric
• Product Code: HBC
• Regulation Number: 882.4360
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIEN-AIR SURGERY SA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZETHON LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	1703	1703
2020	1304	1304
2021	946	946
2022	760	760
2023	664	664
2024	86	86

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	1996	1996
Vibration	954	954
Overheating of Device	829	829
Unintended System Motion	427	427
Device Damaged by Another Device	424	424
Detachment of Device or Device Component	413	413
Device Alarm System	276	276
Complete Loss of Power	251	251
Noise, Audible	170	170
Material Twisted/Bent	156	156
Break	149	149
Device-Device Incompatibility	136	136
Fail-Safe Did Not Operate	131	131
Material Fragmentation	109	109
Appropriate Term/Code Not Available	94	94
Mechanical Jam	57	57
Material Frayed	47	47
Leak/Splash	42	42
Separation Problem	42	42
Output below Specifications	39	39
Fail-Safe Problem	33	33
Fracture	31	31
Premature Separation	30	30
Difficult or Delayed Separation	26	26
Device Slipped	23	23
Mechanical Problem	23	23
Fluid/Blood Leak	22	22
Environmental Particulates	15	15
Device Reprocessing Problem	15	15
No Apparent Adverse Event	12	12
Component Missing	9	9
Electrical /Electronic Property Problem	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Unintended Movement	9	9
Intermittent Loss of Power	8	8
Dull, Blunt	7	7
Device Markings/Labelling Problem	7	7
Connection Problem	6	6
Separation Failure	5	5
Physical Resistance/Sticking	5	5
Material Rupture	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Device Remains Activated	4	4
Corroded	4	4
Device Fell	3	3
Power Problem	3	3
Self-Activation or Keying	3	3
Contamination /Decontamination Problem	3	3
Retraction Problem	3	3
Naturally Worn	3	3
Component or Accessory Incompatibility	3	3
Loss of Power	2	2
Material Deformation	2	2
Display or Visual Feedback Problem	2	2
Mechanics Altered	2	2
Intermittent Energy Output	2	2
Degraded	2	2
Device Displays Incorrect Message	2	2
Misconnection	2	2
False Alarm	1	1
Energy Output Problem	1	1
Product Quality Problem	1	1
Unstable	1	1
Excessive Cooling	1	1
Energy Spectrum Incorrect	1	1
Intermittent Continuity	1	1
Circuit Failure	1	1
Output above Specifications	1	1
Component Misassembled	1	1
Failure to Eject	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Auto Stop	1	1
Structural Problem	1	1
Use of Device Problem	1	1
Smoking	1	1
Defective Alarm	1	1
Device Damaged Prior to Use	1	1
Material Too Soft/Flexible	1	1
Difficult to Open or Remove Packaging Material	1	1
Defective Device	1	1
Crack	1	1
Packaging Problem	1	1
Incomplete or Inadequate Connection	1	1
Material Separation	1	1
Positioning Failure	1	1
Protective Measures Problem	1	1
Application Program Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2569	2569
No Consequences Or Impact To Patient	2298	2298
No Known Impact Or Consequence To Patient	548	548
Insufficient Information	18	18
Burn(s)	11	11
Foreign Body In Patient	6	6
Unspecified Tissue Injury	5	5
Full thickness (Third Degree) Burn	3	3
Tissue Damage	3	3
Burn, Thermal	3	3
Failure of Implant	2	2
Perforation	2	2
Brain Injury	2	2
Injury	2	2
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unintended Radiation Exposure	1	1
Patient Problem/Medical Problem	1	1
Peroneal Nerve Palsy	1	1
Post Traumatic Wound Infection	1	1
Hemorrhage/Bleeding	1	1
Chemical Exposure	1	1
No Patient Involvement	1	1
Aneurysm	1	1
Device Embedded In Tissue or Plaque	1	1
No Information	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	The Anspach Effort, Inc.	II	Jan-07-2023