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	5064	5080
Failure to Cut	1098	1099
Entrapment of Device	833	837
Fracture	713	722
Material Deformation	670	671
Device-Device Incompatibility	642	642
Naturally Worn	234	234
Material Twisted/Bent	202	203
Dull, Blunt	123	123
Material Integrity Problem	100	100
Mechanical Jam	93	93
Contamination /Decontamination Problem	67	68
No Apparent Adverse Event	64	64
Material Fragmentation	49	50
Physical Resistance/Sticking	47	47
Degraded	39	39
Illegible Information	38	38
Adverse Event Without Identified Device or Use Problem	37	38
Corroded	29	29
Appropriate Term/Code Not Available	29	29
Detachment of Device or Device Component	25	26
Improper or Incorrect Procedure or Method	23	23
Scratched Material	18	18
Difficult to Remove	18	18
Device Contaminated During Manufacture or Shipping	16	16
Structural Problem	15	15
Crack	15	15
Mechanical Problem	15	15
Use of Device Problem	15	15
Material Separation	14	14
Overheating of Device	13	13
Component Missing	12	12
Packaging Problem	10	10
Difficult to Advance	9	9
Insufficient Information	8	8
Separation Failure	6	6
Device Dislodged or Dislocated	6	6
Therapeutic or Diagnostic Output Failure	5	5
Unintended Movement	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Flaked	5	5
Difficult to Insert	5	6
Noise, Audible	5	5
Tear, Rip or Hole in Device Packaging	4	4
Delivered as Unsterile Product	4	4
Patient Device Interaction Problem	4	4
Device Markings/Labelling Problem	4	4
Smoking	4	4
Material Split, Cut or Torn	3	4
Activation, Positioning or Separation Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6049	6065
Foreign Body In Patient	1000	1006
Insufficient Information	985	987
No Consequences Or Impact To Patient	724	724
No Code Available	192	192
Device Embedded In Tissue or Plaque	189	190
No Known Impact Or Consequence To Patient	69	70
No Patient Involvement	43	43
Not Applicable	41	41
Injury	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
No Information	18	18
Bone Fracture(s)	17	18
Unspecified Tissue Injury	17	17
Failure of Implant	12	12
Hemorrhage/Bleeding	6	6
Pain	6	6
Perforation	5	5
Burn(s)	5	5
Unspecified Infection	4	4
Tissue Damage	3	3
Discomfort	3	3
Impaired Healing	2	2
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	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