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	5289	5289
Failure to Cut	1093	1093
Entrapment of Device	831	831
Fracture	688	688
Device-Device Incompatibility	670	670
Material Deformation	652	652
Material Twisted/Bent	348	348
Naturally Worn	250	250
Dull, Blunt	204	204
Mechanical Jam	98	98
Material Integrity Problem	96	96
Contamination /Decontamination Problem	70	70
Physical Resistance/Sticking	61	61
No Apparent Adverse Event	57	57
Material Fragmentation	53	53
Adverse Event Without Identified Device or Use Problem	51	51
Detachment of Device or Device Component	39	39
Illegible Information	38	38
Degraded	35	35
Appropriate Term/Code Not Available	34	34
Corroded	29	29
Improper or Incorrect Procedure or Method	25	25
Scratched Material	21	21
Use of Device Problem	20	20
Difficult to Remove	19	19
Device Contaminated During Manufacture or Shipping	16	16
Unintended Movement	15	15
Material Separation	15	15
Crack	15	15
Component Missing	15	15
Mechanical Problem	14	14
Overheating of Device	13	13
Structural Problem	13	13
Packaging Problem	12	12
Insufficient Information	11	11
Protective Measures Problem	10	10
Separation Failure	8	8
Difficult to Advance	7	7
Difficult to Insert	7	7
Device Contamination with Chemical or Other Material	6	6
Device Dislodged or Dislocated	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Delivered as Unsterile Product	5	5
Flaked	5	5
Noise, Audible	5	5
Failure to Align	5	5
Patient Device Interaction Problem	5	5
Activation, Positioning or Separation Problem	4	4
Smoking	4	4
Tear, Rip or Hole in Device Packaging	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5432	5432
No Consequences Or Impact To Patient	1443	1443
Foreign Body In Patient	1058	1058
Insufficient Information	946	946
No Code Available	279	279
Device Embedded In Tissue or Plaque	209	209
No Known Impact Or Consequence To Patient	164	164
Not Applicable	114	114
No Patient Involvement	92	92
Injury	57	57
No Information	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Unspecified Tissue Injury	17	17
Bone Fracture(s)	17	17
Failure of Implant	12	12
Burn(s)	8	8
Hemorrhage/Bleeding	7	7
Pain	6	6
Patient Problem/Medical Problem	6	6
Unspecified Infection	6	6
Perforation	5	5
Blood Loss	3	3
Discomfort	3	3
Tissue Damage	3	3
Impaired Healing	3	3
Paralysis	2	2
Nerve Damage	2	2
Hypersensitivity/Allergic reaction	2	2
Perforation of Vessels	2	2
Unspecified Musculoskeletal problem	1	1
Hematoma	1	1
Rupture	1	1
Vascular Dissection	1	1
Foreign Body Reaction	1	1
Spinal Column Injury	1	1
Necrosis	1	1
Sepsis	1	1
Pneumothorax	1	1
Fever	1	1
Chills	1	1
Osteomyelitis	1	1
Death	1	1
Loss of Range of Motion	1	1
Swelling	1	1
Osteolysis	1	1
Superficial (First Degree) Burn	1	1
Laceration(s)	1	1
Limb Fracture	1	1
Vessel Or Plaque, Device Embedded In	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AAP Implantate Ag	III	Dec-22-2019
2	Arthrex, Inc.	II	Mar-26-2021
3	Biomet, Inc.	II	Dec-17-2020
4	Flower Orthopedics Corporation	II	Oct-14-2021
5	NEOSTEO	II	Aug-09-2021
6	Paragon 28, Inc.	II	Sep-17-2021
7	Trilliant Surgical, LLC	II	May-05-2020
8	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-06-2024
9	Zimmer GmbH	II	May-23-2019