TPLC - Total Product Life Cycle

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Device	extractor
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWB
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	897	899
Device-Device Incompatibility	443	444
Material Deformation	235	235
Material Twisted/Bent	180	180
Naturally Worn	134	134
Fracture	85	85
Mechanical Jam	67	67
Crack	60	60
Material Integrity Problem	40	40
No Apparent Adverse Event	33	33
Mechanical Problem	16	16
Entrapment of Device	15	15
Contamination /Decontamination Problem	12	13
Scratched Material	11	11
Corroded	11	12
Illegible Information	10	10
Detachment of Device or Device Component	9	9
Structural Problem	9	9
Appropriate Device Problem Term/Code Not Available	8	8
Physical Resistance/Sticking	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Device Slipped	7	7
Difficult to Open or Close	6	6
Unintended Movement	6	6
Use of Device Problem	5	5
Defective Device	5	5
Component Missing	5	5
Damaged Thread	5	5
Difficult to Remove	3	3
Failure to Cut	3	3
Device Damaged by Another Device	2	2
Improper or Incorrect Procedure or Method	2	2
Mechanics Altered	2	2
Material Fragmentation	2	2
Loose or Intermittent Connection	2	2
Device Handling Problem	2	2
Dull, Blunt	2	2
Off-Label Use	2	2
Device Difficult to Maintain	1	1
Insufficient Device Problem Information	1	1
Degraded	1	1
Device Damaged Prior to Use	1	1
Activation, Positioning or Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1546	1548
No Consequences Or Impact To Patient	216	216
Insufficient Information	201	202
No Code Available	52	52
Foreign Body In Patient	22	22
Not Applicable	9	9
No Patient Involvement	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
No Known Impact Or Consequence To Patient	7	7
Bone Fracture(s)	6	6
Failure of Implant	6	6
Pain	3	3
Unspecified Tissue Injury	3	3
Unspecified Nervous System Problem	2	2
Muscle Weakness/Atrophy	2	2
Cerebrospinal Fluid Leakage	2	2
Seroma	2	2
Unspecified Infection	2	2
Numbness	2	2
Injury	2	2
Rheumatoid Arthritis	1	1
Necrosis	1	1
Device Embedded In Tissue or Plaque	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Innomed, Inc.	II	May-01-2024