TPLC - Total Product Life Cycle

• Device: hammer, surgical
• Product Code: FZY
• Regulation Number: 878.4800
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	75	75
2020	79	79
2021	69	69
2022	68	68
2023	79	79
2024	52	52

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	213	213
Device-Device Incompatibility	89	89
Material Twisted/Bent	66	66
Naturally Worn	55	55
Contamination /Decontamination Problem	28	28
Material Deformation	20	20
Material Integrity Problem	8	8
Physical Resistance/Sticking	4	4
Mechanical Jam	4	4
Crack	3	3
Scratched Material	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Illegible Information	3	3
Device Slipped	2	2
Device Damaged Prior to Use	2	2
Device Contamination with Chemical or Other Material	2	2
No Apparent Adverse Event	2	2
Fracture	2	2
Appropriate Term/Code Not Available	2	2
Entrapment of Device	1	1
Mechanical Problem	1	1
Separation Failure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Positioning Problem	1	1
Patient Device Interaction Problem	1	1
Positioning Failure	1	1
Component Missing	1	1
Unexpected Therapeutic Results	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	266	266
No Consequences Or Impact To Patient	109	109
No Patient Involvement	20	20
No Code Available	18	18
Insufficient Information	17	17
Not Applicable	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Known Impact Or Consequence To Patient	2	2
Skin Infection	1	1