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	4282	4294
Material Twisted/Bent	2701	2704
Device-Device Incompatibility	1617	1620
Fracture	914	916
Material Deformation	627	627
Naturally Worn	436	438
Material Integrity Problem	265	267
Contamination /Decontamination Problem	158	158
Entrapment of Device	149	149
Calibration Problem	145	145
Mechanical Jam	98	100
Crack	87	87
Detachment of Device or Device Component	82	82
Mechanical Problem	78	78
Compatibility Problem	77	77
Material Separation	65	70
Connection Problem	53	53
Material Fragmentation	46	46
Unintended Movement	45	45
Appropriate Term/Code Not Available	44	44
Use of Device Problem	35	35
No Apparent Adverse Event	31	31
Device Slipped	30	30
Defective Device	27	27
Illegible Information	25	25
Physical Resistance/Sticking	19	20
Adverse Event Without Identified Device or Use Problem	19	19
Component Missing	16	16
Corroded	15	15
Material Discolored	15	15
Scratched Material	14	14
Mechanics Altered	14	14
Degraded	12	12
Difficult to Remove	11	11
Improper or Incorrect Procedure or Method	9	9
Loose or Intermittent Connection	9	9
Electrical /Electronic Property Problem	9	9
Device Difficult to Setup or Prepare	9	9
Insufficient Information	8	8
Noise, Audible	7	7
Structural Problem	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Activation, Positioning or Separation Problem	6	6
Off-Label Use	6	6
Device Handling Problem	6	6
Device Reprocessing Problem	5	5
Packaging Problem	5	5
Dull, Blunt	4	4
Deformation Due to Compressive Stress	4	4
Fitting Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8435	8459
No Consequences Or Impact To Patient	851	851
Insufficient Information	719	720
Foreign Body In Patient	283	283
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	73	74
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	12	12
Failure of Implant	9	10
Hemorrhage/Bleeding	5	5
Bone Fracture(s)	3	3
Blood Loss	3	3
Skull Fracture	2	2
Exsanguination	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