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	864	878
Device-Device Incompatibility	722	728
Break	447	456
Migration	116	116
Fracture	104	105
Material Deformation	77	78
Manufacturing, Packaging or Shipping Problem	62	62
Detachment of Device or Device Component	46	47
Material Twisted/Bent	41	41
Migration or Expulsion of Device	31	32
Use of Device Problem	19	19
Crack	18	18
Device Slipped	16	16
Material Integrity Problem	16	16
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	11	11
No Apparent Adverse Event	9	9
Failure to Align	8	8
Device Dislodged or Dislocated	7	7
Insufficient Information	7	7
Illegible Information	6	6
Defective Device	6	6
Device Contaminated During Manufacture or Shipping	5	5
Naturally Worn	5	5
Malposition of Device	5	5
Mechanical Jam	4	4
Appropriate Term/Code Not Available	4	4
Missing Information	4	4
Tear, Rip or Hole in Device Packaging	4	4
Connection Problem	3	3
Component Missing	3	4
Positioning Failure	3	3
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	1126	1138
Non-union Bone Fracture	325	328
Insufficient Information	295	296
Failure of Implant	208	209
Unspecified Infection	137	145
Pain	131	133
Bone Fracture(s)	89	91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	81	81
Physical Asymmetry	68	71
Post Operative Wound Infection	47	47
Deformity/ Disfigurement	47	48
Malunion of Bone	46	46
Discomfort	30	30
Thrombosis/Thrombus	26	26
Skin Inflammation/ Irritation	25	25
Loss of Range of Motion	23	23
Implant Pain	21	22
Impaired Healing	19	19
Foreign Body In Patient	19	20
Necrosis	19	19
Perforation	19	19
Inflammation	19	19
Ambulation Difficulties	16	16
Unspecified Tissue Injury	15	15
Fall	14	14
Limb Fracture	12	12
Device Embedded In Tissue or Plaque	10	10
Swelling/ Edema	10	10
Nerve Damage	10	10
Hip Fracture	10	10
Inadequate Osseointegration	8	8
Bacterial Infection	8	8
Muscular Rigidity	8	8
Hematoma	7	7
Ossification	7	8
Muscle Weakness	6	6
Fluid Discharge	6	6
Skin Infection	5	5
Osteomyelitis	5	5
Cellulitis	4	6
Paralysis	4	4
Arthralgia	4	4
Unequal Limb Length	4	4
Hypersensitivity/Allergic reaction	4	4
Muscle/Tendon Damage	3	3
Joint Dislocation	3	3
Abscess	2	2
Balance Problems	2	2
Scar Tissue	2	2
Laceration(s)	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