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	875	888
Device-Device Incompatibility	833	839
Break	481	490
Migration	120	120
Fracture	107	108
Material Deformation	95	96
Manufacturing, Packaging or Shipping Problem	62	62
Detachment of Device or Device Component	49	50
Material Twisted/Bent	45	45
Migration or Expulsion of Device	31	32
Crack	24	24
Material Integrity Problem	21	21
Device Slipped	19	19
Use of Device Problem	19	19
Difficult to Advance	16	16
Loosening of Implant Not Related to Bone-Ingrowth	14	14
Delivered as Unsterile Product	13	13
Improper or Incorrect Procedure or Method	13	13
Entrapment of Device	12	12
Failure to Align	11	11
No Apparent Adverse Event	10	10
Insufficient Device Problem Information	8	8
Device Dislodged or Dislocated	7	7
Defective Device	6	6
Illegible Information	6	6
Tear, Rip or Hole in Device Packaging	5	5
Naturally Worn	5	5
Malposition of Device	5	5
Mechanical Jam	5	5
Device Contaminated During Manufacture or Shipping	5	5
Missing Information	4	4
Positioning Failure	4	4
Unsealed Device Packaging	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Scratched Material	3	3
Difficult to Insert	3	3
Connection Problem	3	3
Device Markings/Labelling Problem	3	3
Mechanical Problem	3	3
Nonstandard Device	2	2
Component Misassembled	2	2
Loose or Intermittent Connection	2	2
Deformation Due to Compressive Stress	2	2
Loss of Osseointegration	2	2
Inadequacy of Device Shape and/or Size	2	2
Component Missing	2	3
Patient Device Interaction Problem	2	2
Off-Label Use	2	2
Fitting Problem	2	2
Product Quality Problem	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1301	1313
Nonunion/Delayed-union Bone Fracture	333	336
Insufficient Information	310	311
Failure of Implant	208	209
Unspecified Infection	143	151
Pain	132	134
Bone Fracture(s)	91	93
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	81	81
Physical Asymmetry	69	72
Malunion of Bone	49	49
Deformity/ Disfigurement	48	49
Post Operative Wound Infection	47	47
Discomfort	31	31
Skin Inflammation/ Irritation	28	28
Thrombosis/Thrombus	26	26
Loss of Range of Motion	23	23
Implant Pain	22	23
Impaired Healing	19	19
Foreign Body In Patient	19	20
Necrosis	19	19
Inflammation	19	19
Perforation	19	19
Ambulation or Postural Difficulties	16	16
Fall	15	15
Unspecified Tissue Injury	15	15
Limb Fracture	12	12
Nerve Damage	11	11
Hip Fracture	10	10
Device Embedded In Tissue or Plaque	10	10
Swelling/ Edema	10	10
Hematoma	8	8
Bacterial Infection	8	8
Inadequate Osseointegration	8	8
Muscular Rigidity	8	8
Periprosthetic fracture	7	7
Extraskeletal ossification	7	8
Muscle Weakness/Atrophy	6	6
Fluid Discharge	6	6
Skin Infection	5	5
Medical device site infection	5	5
Osteomyelitis	5	5
Cellulitis	4	6
Hypersensitivity/Allergic reaction	4	4
Paralysis	4	4
Unequal Limb Length	4	4
Arthralgia	4	4
Joint Dislocation	4	4
Loss of fracture reduction	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Muscle/Tendon Damage	3	3

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