TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1330	1337
Degraded	229	229
Detachment of Device or Device Component	205	205
Material Deformation	200	202
Mechanical Jam	141	141
Material Twisted/Bent	118	118
Difficult to Open or Close	98	98
Device Damaged by Another Device	96	96
Material Separation	88	88
Fracture	85	86
Device-Device Incompatibility	73	73
Device Contaminated During Manufacture or Shipping	69	69
Use of Device Problem	61	61
Material Fragmentation	57	57
Dull, Blunt	39	39
Physical Resistance/Sticking	30	30
Adverse Event Without Identified Device or Use Problem	28	28
Corroded	24	24
Flaked	23	23
Defective Device	21	21
Leak/Splash	18	18
Appropriate Term/Code Not Available	18	18
Insufficient Information	17	18
Component Missing	17	17
Mechanical Problem	15	15
Contamination /Decontamination Problem	13	13
Device Dislodged or Dislocated	12	12
Failure to Advance	12	12
Delivered as Unsterile Product	12	12
Material Split, Cut or Torn	12	12
Sharp Edges	11	11
Material Integrity Problem	11	11
Crack	11	11
Device Markings/Labelling Problem	10	10
Failure to Cut	10	10
Positioning Failure	8	9
Loose or Intermittent Connection	8	8
Packaging Problem	8	8
Scratched Material	8	8
Firing Problem	8	8
Failure to Cycle	7	7
Device Damaged Prior to Use	7	7
Unstable	6	6
Display or Visual Feedback Problem	6	6
Entrapment of Device	5	5
Difficult to Remove	5	5
Contamination	5	5
Failure to Align	5	5
Connection Problem	5	5
Difficult to Advance	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2381	2388
Insufficient Information	187	187
Foreign Body In Patient	164	166
No Known Impact Or Consequence To Patient	82	82
No Consequences Or Impact To Patient	79	79
No Information	44	44
No Patient Involvement	29	29
Device Embedded In Tissue or Plaque	21	21
Injury	12	12
Pain	11	11
No Code Available	11	11
Perforation	9	9
Tissue Damage	6	6
Failure of Implant	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Not Applicable	5	5
Laceration(s)	5	5
Extravasation	4	4
Unspecified Tissue Injury	4	4
Rupture	3	3
Swelling/ Edema	3	3
Nerve Damage	2	2
Hypersensitivity/Allergic reaction	2	2
Scar Tissue	2	2
Muscle/Tendon Damage	2	2
Unspecified Musculoskeletal problem	1	1
Bone Fracture(s)	1	1
Itching Sensation	1	1
Inadequate Osseointegration	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Sepsis	1	1
Burning Sensation	1	1
Joint Dislocation	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Capsular Contracture	1	1
Joint Laxity	1	1
Neuropathy	1	1
Unspecified Infection	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew, Inc.	II	Oct-27-2020