TPLC - Total Product Life Cycle

• Device: bender
• Product Code: HXW
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	11	11
2016	30	30
2017	22	22
2018	43	43
2019	24	24
2020	16	16
2021	11	11
2022	10	10
2023	12	12
2024	19	19

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	60	60
Fracture	45	45
Material Deformation	27	27
Device Inoperable	16	16
Disassembly	15	15
Material Twisted/Bent	10	10
Device-Device Incompatibility	8	8
Detachment of Device or Device Component	8	8
Device Operates Differently Than Expected	6	6
Mechanical Jam	5	5
Sticking	4	4
Physical Resistance/Sticking	3	3
Mechanical Problem	3	3
Device Operational Issue	3	3
Naturally Worn	2	2
Device Slipped	2	2
Degraded	2	2
Mechanics Altered	2	2
Loose or Intermittent Connection	2	2
Corroded	2	2
Migration or Expulsion of Device	1	1
Device Or Device Fragments Location Unknown	1	1
Difficult to Remove	1	1
Failure To Adhere Or Bond	1	1
Material Fragmentation	1	1
Component Missing	1	1
Device Maintenance Issue	1	1
No Apparent Adverse Event	1	1
Difficult to Open or Close	1	1
Unintended Movement	1	1
Separation Failure	1	1
Difficult to Advance	1	1
Defective Device	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	93	93
No Clinical Signs, Symptoms or Conditions	48	48
No Consequences Or Impact To Patient	34	34
No Code Available	7	7
No Information	7	7
No Patient Involvement	7	7
Sedation	2	2
Injury	1	1
Foreign Body In Patient	1	1
Nerve Damage	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Jul-19-2022
2	Synthes, Inc.	II	Jan-28-2015