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	751	753
Device-Device Incompatibility	378	379
Material Deformation	209	209
Naturally Worn	129	129
Material Twisted/Bent	114	114
Fracture	75	75
Mechanical Jam	53	53
Crack	50	50
Material Integrity Problem	36	36
No Apparent Adverse Event	32	32
Entrapment of Device	14	14
Mechanical Problem	12	12
Corroded	11	12
Contamination /Decontamination Problem	11	12
Illegible Information	8	8
Detachment of Device or Device Component	8	8
Structural Problem	8	8
Scratched Material	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Damaged Thread	5	5
Difficult to Open or Close	5	5
Unintended Movement	5	5
Device Slipped	5	5
Use of Device Problem	5	5
Failure to Cut	3	3
Mechanics Altered	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Device Handling Problem	2	2
Difficult to Remove	2	2
Improper or Incorrect Procedure or Method	2	2
Component Missing	2	2
Degraded	1	1
Material Fragmentation	1	1
Insufficient Device Problem Information	1	1
Off-Label Use	1	1
Device Damaged Prior to Use	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1503	1505
Insufficient Information	198	199
Foreign Body In Patient	21	21
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	6
Bone Fracture(s)	5	5
Failure of Implant	4	4
Unspecified Tissue Injury	3	3
Unspecified Infection	2	2
Muscle Weakness/Atrophy	2	2
Seroma	2	2
Cerebrospinal Fluid Leakage	2	2
Unspecified Nervous System Problem	2	2
Pain	2	2
Numbness	2	2
Rheumatoid Arthritis	1	1
Necrosis	1	1
Discomfort	1	1

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