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	4021	4030
Material Twisted/Bent	2523	2526
Device-Device Incompatibility	1529	1532
Fracture	911	913
Material Deformation	583	583
Naturally Worn	391	393
Material Integrity Problem	276	278
Contamination /Decontamination Problem	165	165
Entrapment of Device	141	141
Material Separation	96	101
Calibration Problem	90	90
Mechanical Jam	87	89
Detachment of Device or Device Component	86	86
Crack	78	78
Mechanical Problem	75	75
Compatibility Problem	72	72
Unintended Movement	41	41
No Apparent Adverse Event	35	35
Use of Device Problem	35	35
Connection Problem	34	34
Appropriate Term/Code Not Available	32	32
Device Slipped	28	28
Material Fragmentation	26	26
Illegible Information	25	25
Scratched Material	20	20
Degraded	18	18
Mechanics Altered	17	17
Material Discolored	16	16
Corroded	15	15
Defective Device	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Insufficient Information	10	10
Electrical /Electronic Property Problem	9	9
Device Difficult to Setup or Prepare	9	9
Physical Resistance/Sticking	9	10
Improper or Incorrect Procedure or Method	8	8
Structural Problem	8	8
Difficult to Remove	7	7
Component Missing	6	6
Off-Label Use	6	6
Device Handling Problem	5	5
Activation, Positioning or Separation Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Deformation Due to Compressive Stress	4	4
Loose or Intermittent Connection	4	4
Fitting Problem	4	4
Failure to Cut	4	4
Noise, Audible	3	3
Failure to Discharge	3	3
Failure to Align	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9024	9045
Insufficient Information	734	735
Foreign Body In Patient	263	263
Device Embedded In Tissue or Plaque	60	61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Unspecified Tissue Injury	10	10
No Consequences Or Impact To Patient	9	9
Hemorrhage/Bleeding	5	5
Failure of Implant	4	5
Bone Fracture(s)	3	3
No Code Available	2	2
Skull Fracture	2	2
Perforation	2	2
Perforation of Vessels	2	2
Unspecified Infection	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
No Information	1	1
Skin Inflammation/ Irritation	1	1
Ossification	1	1
Laceration(s)	1	1
Pain	1	1
Non-union Bone Fracture	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