TPLC - Total Product Life Cycle

• Device: cutter, wire
• Product Code: HXZ
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2016	33	33
2017	25	25
2018	26	26
2019	36	36
2020	24	24
2021	44	44
2022	37	37
2023	33	33
2024	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	156	156
Material Integrity Problem	29	29
Fracture	22	22
Failure to Cut	14	14
Dull, Blunt	12	12
Material Fragmentation	9	9
Material Deformation	7	7
Mechanical Problem	6	6
Device Operates Differently Than Expected	5	5
Device Inoperable	4	4
Component Missing	4	4
Contamination /Decontamination Problem	4	4
Crack	3	3
Mechanical Jam	3	3
Naturally Worn	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Activation, Positioning or Separation Problem	2	2
Flaked	2	2
Corroded	1	1
Delivered as Unsterile Product	1	1
Device Slipped	1	1
Material Frayed	1	1
Delamination	1	1
Defective Device	1	1
Bent	1	1
Detachment of Device or Device Component	1	1
Material Twisted/Bent	1	1
Device Operational Issue	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Compatibility Problem	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	119	119
No Known Impact Or Consequence To Patient	46	46
No Consequences Or Impact To Patient	43	43
No Patient Involvement	37	37
No Code Available	12	12
Foreign Body In Patient	7	7
Insufficient Information	6	6
No Information	5	5
Device Embedded In Tissue or Plaque	2	2
Alteration In Body Temperature	1	1
Brain Injury	1	1
Spinal Cord Injury	1	1
Blood Loss	1	1
Hemorrhage/Bleeding	1	1
Laceration(s)	1	1
Tissue Damage	1	1
Weakness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Biomet, Inc.	II	Dec-22-2020