TPLC - Total Product Life Cycle

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Device	instrument, manual, surgical, general use
Regulation Description	Manual surgical instrument for general use.
Product Code	MDM
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1082	1083
Physical Resistance/Sticking	70	70
Material Twisted/Bent	62	62
Adverse Event Without Identified Device or Use Problem	54	54
Difficult to Remove	50	50
Entrapment of Device	49	49
Detachment of Device or Device Component	46	46
Dull, Blunt	41	41
Fracture	41	44
Material Fragmentation	40	40
Defective Device	23	23
Corroded	19	19
Appropriate Term/Code Not Available	19	19
Mechanical Jam	19	19
Material Separation	17	17
Use of Device Problem	17	17
Material Split, Cut or Torn	15	16
Component Missing	13	13
Mechanical Problem	12	12
Patient Device Interaction Problem	12	12
Flaked	11	11
Device Damaged by Another Device	11	11
Fitting Problem	11	11
Material Deformation	10	10
Connection Problem	9	9
Failure to Disinfect	8	8
Naturally Worn	7	7
Failure to Cut	7	7
Activation, Positioning or Separation Problem	7	8
Difficult to Open or Close	6	6
Crack	6	6
Device Dislodged or Dislocated	6	6
Failure to Advance	6	6
Unintended Movement	6	6
Device-Device Incompatibility	6	6
Positioning Failure	6	6
Output Problem	5	5
Insufficient Information	5	5
Device Difficult to Maintain	5	5
Contamination /Decontamination Problem	5	5
Melted	4	4
Misfire	4	4
Device Slipped	4	4
Difficult to Insert	3	3
Separation Problem	3	3
Device Damaged Prior to Use	3	3
Failure to Fire	3	3
Delivered as Unsterile Product	3	3
Inadequacy of Device Shape and/or Size	3	3
Incorrect Measurement	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	891	897
Insufficient Information	316	317
Foreign Body In Patient	263	264
Device Embedded In Tissue or Plaque	84	84
No Known Impact Or Consequence To Patient	66	66
No Consequences Or Impact To Patient	41	41
No Patient Involvement	31	31
Injury	19	19
Failure of Implant	19	19
Unspecified Infection	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Pain	11	11
Bone Fracture(s)	9	9
No Information	7	7
Unspecified Tissue Injury	6	6
Perforation	6	6
No Code Available	5	5
Pericardial Effusion	4	4
Swelling/ Edema	4	4
Low Blood Pressure/ Hypotension	4	4
Laceration(s)	3	3
Cardiac Tamponade	3	3
Tissue Damage	3	3
Post Operative Wound Infection	3	3
Discomfort	2	2
Perforation of Vessels	2	2
Hemorrhage/Bleeding	2	2
Internal Organ Perforation	2	2
Inflammation	2	2
Purulent Discharge	2	2
Joint Laxity	2	2
Metal Related Pathology	2	2
Heart Block	2	2
Not Applicable	2	2
Vascular Dissection	1	1
Subluxation	1	1
Increased Appetite	1	1
Edema	1	1
Hematoma	1	1
Wound Dehiscence	1	1
Bacterial Infection	1	1
Exposure to Body Fluids	1	1
Bruise/Contusion	1	1
Hypoxia	1	1
Damage to Ligament(s)	1	1
Muscular Rigidity	1	1
Hip Fracture	1	1
Arthralgia	1	1
Non-union Bone Fracture	1	1
Joint Dislocation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	II	Mar-27-2024
2	Arthrex, Inc.	II	Dec-08-2022
3	ENDO Pharmaceuticals Solutions, Inc.	II	Dec-30-2022
4	FlexDex Inc.	II	Jan-27-2022
5	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
6	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
8	Sklar Instruments	II	Jan-16-2025
9	Technicality Inc.	II	Apr-02-2024