TPLC - Total Product Life Cycle

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

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	123	123
Material Integrity Problem	31	31
Fracture	18	18
Failure to Cut	13	13
Dull, Blunt	11	11
Material Deformation	7	7
Mechanical Problem	6	6
Contamination /Decontamination Problem	4	4
Material Fragmentation	3	3
Device Operates Differently Than Expected	3	3
Naturally Worn	3	3
Mechanical Jam	3	3
Crack	3	3
Device Slipped	2	2
Activation, Positioning or Separation Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Detachment of Device or Device Component	2	2
Compatibility Problem	1	1
Material Frayed	1	1
Device-Device Incompatibility	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Difficult to Open or Close	1	1
Flaked	1	1
Corroded	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1
Defective Device	1	1
Delivered as Unsterile Product	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	128	128
No Consequences Or Impact To Patient	38	38
No Patient Involvement	19	19
No Known Impact Or Consequence To Patient	15	15
Insufficient Information	9	9
No Code Available	7	7
Foreign Body In Patient	5	5
No Information	3	3
Brain Injury	1	1
Blood Loss	1	1
Alteration In Body Temperature	1	1
Weakness	1	1
Laceration(s)	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1
Spinal Cord Injury	1	1
Device Embedded In Tissue or Plaque	1	1

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