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	4887	4900
Failure to Cut	1062	1063
Entrapment of Device	761	765
Fracture	715	723
Material Deformation	653	654
Device-Device Incompatibility	580	580
Naturally Worn	210	210
Material Integrity Problem	98	98
Material Twisted/Bent	87	88
No Apparent Adverse Event	72	72
Mechanical Jam	67	67
Contamination /Decontamination Problem	63	64
Material Fragmentation	49	50
Degraded	38	38
Physical Resistance/Sticking	37	37
Adverse Event Without Identified Device or Use Problem	26	27
Dull, Blunt	26	26
Crack	25	25
Improper or Incorrect Procedure or Method	24	24
Detachment of Device or Device Component	20	20
Scratched Material	19	19
Use of Device Problem	17	17
Appropriate Device Problem Term/Code Not Available	16	16
Structural Problem	13	13
Mechanical Problem	12	12
Overheating of Device	12	12
Corroded	11	11
Device Contaminated During Manufacture or Shipping	10	10
Difficult to Advance	10	10
Illegible Information	9	9
Unintended Movement	8	8
Insufficient Device Problem Information	7	7
Separation Failure	7	7
Packaging Problem	6	6
Device Dislodged or Dislocated	5	5
Difficult to Insert	5	6
Tear, Rip or Hole in Device Packaging	5	5
Noise, Audible	5	5
Smoking	4	4
Patient Device Interaction Problem	4	4
Material Split, Cut or Torn	4	5
Manufacturing, Packaging or Shipping Problem	4	4
Material Separation	4	4
Difficult to Remove	3	3
Failure to Align	3	3
Delivered as Unsterile Product	3	3
Unclear Information	3	3
Activation, Positioning or Separation Problem	3	3
Flaked	2	2
Failure to Advance	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6751	6767
Insufficient Information	994	996
Foreign Body In Patient	931	937
Device Embedded In Tissue or Plaque	168	168
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	17	17
Unspecified Tissue Injury	15	15
Bone Fracture(s)	13	14
Failure of Implant	7	7
Pain	6	6
Burn(s)	5	5
Perforation	5	5
No Patient Involvement	4	4
Bone Notching	4	4
No Known Impact Or Consequence To Patient	4	4
Unspecified Infection	4	4
Discomfort	4	4
Impaired Healing	2	2
Bacterial Infection	2	2
Nerve Damage	2	2
Hypersensitivity/Allergic reaction	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Foreign Body Reaction	1	1
Fever	1	1
Deformity/ Disfigurement	1	1
Hematoma	1	1
Arthritis	1	1
Vertebral Fracture	1	1
Full thickness (Third Degree) Burn	1	1
Swelling/ Edema	1	1
Cartilage damage	1	1
Rupture	1	1
Sepsis	1	1
Low Oxygen Saturation	1	1
Chills	1	1
Thromboembolism	1	1
Unspecified Musculoskeletal problem	1	1
Osteolysis	1	1
Osteomyelitis	1	1
Necrosis	1	1
Perforation of Vessels	1	1
Limb Fracture	1	1
Vascular Dissection	1	1
Ischemia Stroke	1	1
Superficial (First Degree) Burn	1	1
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrex, Inc.	II	Mar-26-2021
2	Flower Orthopedics Corporation	II	Oct-14-2021
3	NEOSTEO	II	Aug-09-2021
4	Paragon 28, Inc.	II	Sep-17-2021
5	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-27-2026
6	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-06-2024