TPLC - Total Product Life Cycle

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Device	nail, fixation, bone
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	JDS
Regulation Number	888.3030
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	867	881
Device-Device Incompatibility	769	775
Break	455	464
Migration	117	117
Fracture	104	105
Material Deformation	83	84
Manufacturing, Packaging or Shipping Problem	62	62
Detachment of Device or Device Component	48	49
Material Twisted/Bent	43	43
Migration or Expulsion of Device	31	32
Material Integrity Problem	21	21
Use of Device Problem	19	19
Crack	18	18
Device Slipped	17	17
Difficult to Advance	14	14
Loosening of Implant Not Related to Bone-Ingrowth	14	14
Improper or Incorrect Procedure or Method	13	13
Entrapment of Device	13	13
Delivered as Unsterile Product	13	13
Failure to Align	10	10
No Apparent Adverse Event	9	9
Device Dislodged or Dislocated	7	7
Insufficient Information	7	7
Illegible Information	6	6
Defective Device	6	6
Mechanical Jam	5	5
Device Contaminated During Manufacture or Shipping	5	5
Naturally Worn	5	5
Malposition of Device	5	5
Tear, Rip or Hole in Device Packaging	5	5
Appropriate Term/Code Not Available	4	4
Missing Information	4	4
Positioning Failure	4	4
Connection Problem	3	3
Component Missing	3	4
Difficult to Insert	3	3
Scratched Material	3	3
Unsealed Device Packaging	3	3
Device Markings/Labelling Problem	3	3
Mechanical Problem	3	3
Patient Device Interaction Problem	2	2
Product Quality Problem	2	3
Inadequacy of Device Shape and/or Size	2	2
Component Misassembled	2	2
Unintended Movement	2	2
Nonstandard Device	2	2
Loose or Intermittent Connection	2	2
Deformation Due to Compressive Stress	2	2
Fitting Problem	2	2
Loss of Osseointegration	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1194	1206
Non-union Bone Fracture	326	329
Insufficient Information	296	297
Failure of Implant	208	209
Unspecified Infection	139	147
Pain	131	133
Bone Fracture(s)	89	91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	81	81
Physical Asymmetry	68	71
Deformity/ Disfigurement	47	48
Post Operative Wound Infection	47	47
Malunion of Bone	46	46
Discomfort	31	31
Thrombosis/Thrombus	26	26
Skin Inflammation/ Irritation	25	25
Loss of Range of Motion	23	23
Implant Pain	21	22
Impaired Healing	19	19
Necrosis	19	19
Inflammation	19	19
Perforation	19	19
Foreign Body In Patient	19	20
Ambulation Difficulties	16	16
Unspecified Tissue Injury	15	15
Fall	14	14
Limb Fracture	12	12
Hip Fracture	10	10
Swelling/ Edema	10	10
Device Embedded In Tissue or Plaque	10	10
Nerve Damage	10	10
Inadequate Osseointegration	8	8
Muscular Rigidity	8	8
Bacterial Infection	8	8
Ossification	7	8
Hematoma	7	7
Muscle Weakness	6	6
Fluid Discharge	6	6
Osteomyelitis	5	5
Skin Infection	5	5
Cellulitis	4	6
Paralysis	4	4
Hypersensitivity/Allergic reaction	4	4
Unequal Limb Length	4	4
Arthralgia	4	4
Joint Dislocation	3	3
Muscle/Tendon Damage	3	3
Anemia	2	2
Confusion/ Disorientation	2	2
Purulent Discharge	2	2
Hemorrhage/Bleeding	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew Orthopaedics GmbH	II	May-25-2022
2	Smith & Nephew, Inc.	II	Jan-06-2021
3	Synthes (USA) Products LLC	II	Oct-21-2025