TPLC - Total Product Life Cycle

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Device	bit, drill
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTW
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4525	4525
Failure to Cut	1063	1063
Entrapment of Device	768	768
Material Deformation	639	639
Fracture	623	623
Device-Device Incompatibility	594	594
Naturally Worn	233	233
Material Twisted/Bent	186	186
Dull, Blunt	123	123
Material Integrity Problem	96	96
Mechanical Jam	92	92
Contamination /Decontamination Problem	66	66
No Apparent Adverse Event	56	56
Physical Resistance/Sticking	45	45
Material Fragmentation	39	39
Illegible Information	38	38
Adverse Event Without Identified Device or Use Problem	37	37
Degraded	34	34
Appropriate Term/Code Not Available	30	30
Corroded	29	29
Improper or Incorrect Procedure or Method	23	23
Detachment of Device or Device Component	20	20
Scratched Material	17	17
Device Contaminated During Manufacture or Shipping	15	15
Material Separation	14	14
Use of Device Problem	14	14
Difficult to Remove	14	14
Overheating of Device	13	13
Structural Problem	13	13
Mechanical Problem	13	13
Crack	13	13
Component Missing	12	12
Protective Measures Problem	10	10
Packaging Problem	10	10
Insufficient Information	7	7
Difficult to Advance	7	7
Separation Failure	6	6
Device Dislodged or Dislocated	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Noise, Audible	5	5
Flaked	5	5
Unintended Movement	5	5
Activation, Positioning or Separation Problem	4	4
Smoking	4	4
Patient Device Interaction Problem	4	4
Difficult to Insert	4	4
Device Markings/Labelling Problem	4	4
Delivered as Unsterile Product	4	4
Therapeutic or Diagnostic Output Failure	3	3
Inaccurate Information	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5432	5432
Insufficient Information	946	946
Foreign Body In Patient	904	904
No Consequences Or Impact To Patient	724	724
No Code Available	192	192
Device Embedded In Tissue or Plaque	166	166
No Known Impact Or Consequence To Patient	69	69
No Patient Involvement	43	43
Not Applicable	41	41
Injury	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
No Information	18	18
Unspecified Tissue Injury	17	17
Bone Fracture(s)	15	15
Failure of Implant	12	12
Hemorrhage/Bleeding	6	6
Perforation	5	5
Burn(s)	5	5
Pain	5	5
Unspecified Infection	4	4
Tissue Damage	3	3
Impaired Healing	2	2
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	2	2
Discomfort	2	2
Perforation of Vessels	2	2
Vertebral Fracture	1	1
Ischemia Stroke	1	1
Full thickness (Third Degree) Burn	1	1
Low Oxygen Saturation	1	1
Arthritis	1	1
Thromboembolism	1	1
Deformity/ Disfigurement	1	1
Bacterial Infection	1	1
Swelling/ Edema	1	1
Limb Fracture	1	1
Laceration(s)	1	1
Osteolysis	1	1
Loss of Range of Motion	1	1
Osteomyelitis	1	1
Chills	1	1
Fever	1	1
Foreign Body Reaction	1	1
Blood Loss	1	1
Rupture	1	1
Hematoma	1	1
Unspecified Musculoskeletal problem	1	1
Vascular Dissection	1	1
Necrosis	1	1
Sepsis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrex, Inc.	II	Mar-26-2021
2	Biomet, Inc.	II	Dec-17-2020
3	Flower Orthopedics Corporation	II	Oct-14-2021
4	NEOSTEO	II	Aug-09-2021
5	Paragon 28, Inc.	II	Sep-17-2021
6	Trilliant Surgical, LLC	II	May-05-2020
7	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-06-2024