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	4298	4298
Failure to Cut	1019	1019
Entrapment of Device	739	739
Material Deformation	613	613
Fracture	580	580
Device-Device Incompatibility	573	573
Naturally Worn	233	233
Material Twisted/Bent	183	183
Dull, Blunt	119	119
Material Integrity Problem	93	93
Mechanical Jam	91	91
Contamination /Decontamination Problem	65	65
No Apparent Adverse Event	51	51
Physical Resistance/Sticking	45	45
Illegible Information	38	38
Material Fragmentation	37	37
Adverse Event Without Identified Device or Use Problem	35	35
Appropriate Term/Code Not Available	30	30
Degraded	30	30
Corroded	28	28
Improper or Incorrect Procedure or Method	22	22
Detachment of Device or Device Component	17	17
Scratched Material	16	16
Device Contaminated During Manufacture or Shipping	14	14
Material Separation	14	14
Difficult to Remove	14	14
Use of Device Problem	14	14
Overheating of Device	13	13
Crack	13	13
Component Missing	12	12
Mechanical Problem	11	11
Structural Problem	11	11
Protective Measures Problem	10	10
Packaging Problem	10	10
Insufficient Information	7	7
Separation Failure	6	6
Difficult to Advance	6	6
Noise, Audible	5	5
Flaked	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Patient Device Interaction Problem	4	4
Activation, Positioning or Separation Problem	4	4
Device Dislodged or Dislocated	4	4
Device Markings/Labelling Problem	4	4
Delivered as Unsterile Product	4	4
Unintended Movement	4	4
Smoking	4	4
Difficult to Insert	3	3
Inaccurate Information	3	3
Material Split, Cut or Torn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5183	5183
Insufficient Information	869	869
Foreign Body In Patient	864	864
No Consequences Or Impact To Patient	724	724
No Code Available	192	192
Device Embedded In Tissue or Plaque	158	158
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	16	16
Bone Fracture(s)	15	15
Failure of Implant	12	12
Hemorrhage/Bleeding	6	6
Pain	5	5
Burn(s)	5	5
Perforation	4	4
Unspecified Infection	4	4
Tissue Damage	3	3
Nerve Damage	2	2
Discomfort	2	2
Hypersensitivity/Allergic reaction	2	2
Perforation of Vessels	2	2
Impaired Healing	2	2
Hematoma	1	1
Rupture	1	1
Blood Loss	1	1
Foreign Body Reaction	1	1
Unspecified Musculoskeletal problem	1	1
Vascular Dissection	1	1
Necrosis	1	1
Fever	1	1
Chills	1	1
Sepsis	1	1
Loss of Range of Motion	1	1
Osteolysis	1	1
Patient Problem/Medical Problem	1	1
Laceration(s)	1	1
Limb Fracture	1	1
Superficial (First Degree) Burn	1	1
Swelling/ Edema	1	1
Vessel Or Plaque, Device Embedded In	1	1
Bacterial Infection	1	1
Deformity/ Disfigurement	1	1
Thromboembolism	1	1
Low Oxygen Saturation	1	1
Full thickness (Third Degree) Burn	1	1
Ischemia Stroke	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