TPLC - Total Product Life Cycle

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Device	screwdriver
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HXX
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3759	3759
Material Twisted/Bent	2375	2375
Device-Device Incompatibility	1383	1383
Fracture	805	805
Material Deformation	495	495
Naturally Worn	430	430
Material Integrity Problem	242	242
Contamination /Decontamination Problem	149	149
Entrapment of Device	129	129
Calibration Problem	125	125
Mechanical Jam	87	87
Crack	77	77
Compatibility Problem	74	74
Mechanical Problem	72	72
Detachment of Device or Device Component	65	65
Connection Problem	53	53
Material Fragmentation	43	43
Appropriate Term/Code Not Available	38	38
Material Separation	33	38
Unintended Movement	32	32
Use of Device Problem	28	28
No Apparent Adverse Event	27	27
Defective Device	27	27
Device Slipped	26	26
Illegible Information	24	24
Physical Resistance/Sticking	19	19
Adverse Event Without Identified Device or Use Problem	19	19
Component Missing	15	15
Material Discolored	15	15
Corroded	14	14
Scratched Material	14	14
Difficult to Remove	11	11
Device Difficult to Setup or Prepare	9	9
Degraded	9	9
Electrical /Electronic Property Problem	9	9
Loose or Intermittent Connection	9	9
Mechanics Altered	7	7
Improper or Incorrect Procedure or Method	7	7
Noise, Audible	7	7
Structural Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Activation, Positioning or Separation Problem	6	6
Packaging Problem	5	5
Device Reprocessing Problem	5	5
Off-Label Use	5	5
Dull, Blunt	4	4
Fitting Problem	4	4
Device Damaged by Another Device	4	4
Insufficient Information	4	4
Incomplete or Inadequate Connection	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7306	7311
No Consequences Or Impact To Patient	851	851
Insufficient Information	636	636
Foreign Body In Patient	241	241
No Patient Involvement	226	226
No Known Impact Or Consequence To Patient	205	205
No Code Available	112	112
Device Embedded In Tissue or Plaque	66	66
No Information	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Not Applicable	16	16
Injury	16	16
Unspecified Tissue Injury	10	10
Failure of Implant	9	9
Hemorrhage/Bleeding	5	5
Blood Loss	3	3
Skull Fracture	2	2
Exsanguination	2	2
Bone Fracture(s)	2	2
Perforation	2	2
Perforation of Vessels	2	2
Unspecified Infection	1	1
Skin Inflammation/ Irritation	1	1
Ossification	1	1
Laceration(s)	1	1
Pain	1	1
Non-union Bone Fracture	1	1
Joint Laxity	1	1
Tissue Damage	1	1
Spinal Cord Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Jul-19-2022
2	Flower Orthopedics Corporation	II	Jun-01-2021
3	Synthes (USA) Products LLC	II	May-28-2024
4	Trilliant Surgical, LLC	II	Jan-10-2020