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	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	96	96
Material Integrity Problem	21	21
Fracture	17	17
Dull, Blunt	11	11
Failure to Cut	11	11
Mechanical Problem	5	5
Material Deformation	5	5
Crack	3	3
Device Operates Differently Than Expected	3	3
Mechanical Jam	3	3
Naturally Worn	3	3
Contamination /Decontamination Problem	2	2
Material Fragmentation	2	2
Material Frayed	1	1
Corroded	1	1
Delivered as Unsterile Product	1	1
Component Missing	1	1
Defective Device	1	1
Detachment of Device or Device Component	1	1
Difficult to Open or Close	1	1
Material Twisted/Bent	1	1
Packaging Problem	1	1
No Apparent Adverse Event	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	89	89
No Consequences Or Impact To Patient	38	38
No Patient Involvement	19	19
No Known Impact Or Consequence To Patient	15	15
No Code Available	7	7
No Information	3	3
Insufficient Information	2	2
Foreign Body In Patient	2	2
Tissue Damage	1	1
Brain Injury	1	1
Spinal Cord Injury	1	1
Alteration In Body Temperature	1	1
Laceration(s)	1	1
Weakness	1	1
Blood Loss	1	1
Device Embedded In Tissue or Plaque	1	1
Hemorrhage/Bleeding	1	1

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