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	4222	4222
Failure to Cut	1013	1013
Entrapment of Device	722	722
Material Deformation	609	609
Fracture	566	566
Device-Device Incompatibility	562	562
Naturally Worn	233	233
Material Twisted/Bent	181	181
Dull, Blunt	119	119
Material Integrity Problem	92	92
Mechanical Jam	90	90
Contamination /Decontamination Problem	65	65
No Apparent Adverse Event	48	48
Physical Resistance/Sticking	44	44
Illegible Information	37	37
Adverse Event Without Identified Device or Use Problem	35	35
Material Fragmentation	35	35
Degraded	30	30
Appropriate Term/Code Not Available	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
Material Separation	14	14
Device Contaminated During Manufacture or Shipping	14	14
Difficult to Remove	14	14
Crack	13	13
Use of Device Problem	13	13
Overheating of Device	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
Difficult to Advance	6	6
Separation Failure	5	5
Noise, Audible	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Flaked	5	5
Unintended Movement	4	4
Device Dislodged or Dislocated	4	4
Patient Device Interaction Problem	4	4
Delivered as Unsterile Product	4	4
Smoking	4	4
Device Markings/Labelling Problem	4	4
Tear, Rip or Hole in Device Packaging	3	3
Activation, Positioning or Separation Problem	3	3
Inaccurate Information	3	3
Difficult to Insert	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5125	5125
Foreign Body In Patient	841	841
Insufficient Information	835	835
No Consequences Or Impact To Patient	724	724
No Code Available	192	192
Device Embedded In Tissue or Plaque	155	155
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
Perforation of Vessels	2	2
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	2	2
Impaired Healing	2	2
Discomfort	2	2
Patient Problem/Medical Problem	1	1
Vascular Dissection	1	1
Low Oxygen Saturation	1	1
Full thickness (Third Degree) Burn	1	1
Thromboembolism	1	1
Vessel Or Plaque, Device Embedded In	1	1
Osteolysis	1	1
Laceration(s)	1	1
Necrosis	1	1
Fever	1	1
Chills	1	1
Unspecified Musculoskeletal problem	1	1
Foreign Body Reaction	1	1
Rupture	1	1
Hematoma	1	1
Blood Loss	1	1
Swelling/ Edema	1	1
Deformity/ Disfigurement	1	1
Loss of Range of Motion	1	1
Limb Fracture	1	1
Bacterial Infection	1	1
Sepsis	1	1
Ischemia Stroke	1	1
Superficial (First Degree) Burn	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