TPLC - Total Product Life Cycle

show TPLC since

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	4674	4688
Failure to Cut	1007	1008
Entrapment of Device	744	748
Fracture	667	675
Material Deformation	606	607
Device-Device Incompatibility	558	558
Naturally Worn	212	212
Material Integrity Problem	92	92
Material Twisted/Bent	83	84
No Apparent Adverse Event	68	68
Mechanical Jam	67	67
Contamination /Decontamination Problem	61	62
Material Fragmentation	48	49
Physical Resistance/Sticking	38	38
Degraded	38	38
Dull, Blunt	26	26
Adverse Event Without Identified Device or Use Problem	26	27
Improper or Incorrect Procedure or Method	24	24
Detachment of Device or Device Component	23	23
Appropriate Term/Code Not Available	17	17
Use of Device Problem	16	16
Scratched Material	16	16
Crack	15	15
Difficult to Remove	15	15
Structural Problem	13	13
Overheating of Device	12	12
Mechanical Problem	12	12
Corroded	11	11
Device Contaminated During Manufacture or Shipping	10	10
Difficult to Advance	9	9
Illegible Information	9	9
Insufficient Information	8	8
Separation Failure	7	7
Device Dislodged or Dislocated	6	6
Packaging Problem	6	6
Noise, Audible	5	5
Material Separation	5	5
Difficult to Insert	5	6
Unintended Movement	5	5
Patient Device Interaction Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Tear, Rip or Hole in Device Packaging	4	4
Smoking	4	4
Activation, Positioning or Separation Problem	3	3
Component Missing	3	3
Nonstandard Device	3	4
Material Split, Cut or Torn	3	4
Failure to Advance	3	3
Therapeutic or Diagnostic Output Failure	3	3
Unclear Information	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6222	6238
Insufficient Information	983	985
Foreign Body In Patient	878	884
Device Embedded In Tissue or Plaque	158	158
Appropriate Clinical Signs, Symptoms, 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
Perforation	5	5
Burn(s)	5	5
Unspecified Infection	4	4
No Patient Involvement	4	4
No Known Impact Or Consequence To Patient	4	4
Discomfort	3	3
Impaired Healing	2	2
Bacterial Infection	2	2
Hemorrhage/Bleeding	2	2
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	2	2
Hematoma	1	1
Arthritis	1	1
Fever	1	1
Foreign Body Reaction	1	1
Laceration(s)	1	1
Necrosis	1	1
Sepsis	1	1
Perforation of Vessels	1	1
Chills	1	1
Rupture	1	1
Low Oxygen Saturation	1	1
Deformity/ Disfigurement	1	1
Osteolysis	1	1
Full thickness (Third Degree) Burn	1	1
Vascular Dissection	1	1
Thromboembolism	1	1
Superficial (First Degree) Burn	1	1
Swelling/ Edema	1	1
Ischemia Stroke	1	1
Limb Fracture	1	1
Vertebral Fracture	1	1
Osteomyelitis	1	1
Unspecified Musculoskeletal problem	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-06-2024