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	821	821
Device-Device Incompatibility	402	402
Material Deformation	205	205
Material Twisted/Bent	163	163
Naturally Worn	134	134
Fracture	76	76
Mechanical Jam	63	63
Crack	56	56
Material Integrity Problem	32	32
No Apparent Adverse Event	20	20
Entrapment of Device	16	16
Mechanical Problem	16	16
Contamination /Decontamination Problem	12	12
Scratched Material	11	11
Corroded	9	9
Detachment of Device or Device Component	9	9
Appropriate Term/Code Not Available	8	8
Illegible Information	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Physical Resistance/Sticking	7	7
Device Slipped	7	7
Difficult to Remove	6	6
Use of Device Problem	6	6
Structural Problem	6	6
Difficult to Open or Close	6	6
Defective Device	5	5
Unintended Movement	4	4
Material Fragmentation	3	3
Component Missing	3	3
Failure to Cut	3	3
Loose or Intermittent Connection	3	3
Device Damaged by Another Device	2	2
Mechanics Altered	2	2
Off-Label Use	2	2
Improper or Incorrect Procedure or Method	2	2
Dull, Blunt	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Degraded	1	1
Defective Component	1	1
Device Difficult to Maintain	1	1
Device Handling Problem	1	1
Device Damaged Prior to Use	1	1
Activation Problem	1	1
Output Problem	1	1
Activation, Positioning or Separation Problem	1	1
Unintended Collision	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1351	1351
No Consequences Or Impact To Patient	216	216
Insufficient Information	193	193
No Code Available	52	52
Foreign Body In Patient	20	20
Not Applicable	9	9
No Patient Involvement	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
No Known Impact Or Consequence To Patient	7	7
Failure of Implant	6	6
Bone Fracture(s)	5	5
Pain	3	3
Unspecified Tissue Injury	3	3
Unspecified Infection	2	2
Muscle Weakness	2	2
Unspecified Nervous System Problem	2	2
Seroma	2	2
Injury	2	2
Numbness	2	2
Cerebrospinal Fluid Leakage	2	2
Rheumatoid Arthritis	1	1
Necrosis	1	1
Discomfort	1	1
Device Embedded In Tissue or Plaque	1	1

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