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	934	935
Physical Resistance/Sticking	68	68
Material Twisted/Bent	56	56
Entrapment of Device	43	43
Difficult to Remove	39	39
Detachment of Device or Device Component	36	36
Dull, Blunt	34	34
Material Fragmentation	33	33
Adverse Event Without Identified Device or Use Problem	32	32
Fracture	27	30
Defective Device	23	23
Corroded	18	18
Material Split, Cut or Torn	14	15
Use of Device Problem	14	14
Mechanical Jam	13	13
Fitting Problem	11	11
Appropriate Term/Code Not Available	11	11
Device Damaged by Another Device	11	11
Patient Device Interaction Problem	11	11
Mechanical Problem	10	10
Flaked	10	10
Component Missing	8	8
Activation, Positioning or Separation Problem	7	8
Failure to Cut	7	7
Device Dislodged or Dislocated	6	6
Material Separation	6	6
Material Deformation	6	6
Unintended Movement	6	6
Difficult to Open or Close	6	6
Positioning Failure	6	6
Failure to Advance	5	5
Output Problem	5	5
Device Difficult to Maintain	5	5
Contamination /Decontamination Problem	5	5
Crack	4	4
Melted	4	4
Connection Problem	4	4
Inadequacy of Device Shape and/or Size	3	3
Incorrect Measurement	3	3
Misfire	3	3
Naturally Worn	3	3
Insufficient Information	3	3
Device Damaged Prior to Use	3	3
Separation Problem	3	3
Device-Device Incompatibility	3	3
Difficult to Insert	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Failure to Clean Adequately	2	2
Material Integrity Problem	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	852	858
Insufficient Information	308	309
Foreign Body In Patient	243	244
Device Embedded In Tissue or Plaque	50	50
Failure of Implant	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Bone Fracture(s)	9	9
Unspecified Infection	7	7
Pain	7	7
Perforation	6	6
Unspecified Tissue Injury	6	6
Low Blood Pressure/ Hypotension	4	4
Pericardial Effusion	4	4
Cardiac Tamponade	3	3
Laceration(s)	3	3
Internal Organ Perforation	2	2
Heart Block	2	2
Metal Related Pathology	2	2
Hemorrhage/Bleeding	2	2
No Consequences Or Impact To Patient	2	2
Inflammation	2	2
Tissue Damage	2	2
Perforation of Vessels	2	2
Discomfort	2	2
Swelling/ Edema	2	2
Joint Laxity	2	2
Bruise/Contusion	1	1
Bacterial Infection	1	1
Hypoxia	1	1
Non-union Bone Fracture	1	1
Subluxation	1	1
Increased Appetite	1	1
Cardiogenic Shock	1	1
Exposure to Body Fluids	1	1
Muscular Rigidity	1	1
Loss of Range of Motion	1	1
No Known Impact Or Consequence To Patient	1	1
Obstruction/Occlusion	1	1
Hematoma	1	1
Synovitis	1	1
Vascular Dissection	1	1
Sepsis	1	1
Joint Dislocation	1	1
Hip Fracture	1	1
Arthralgia	1	1
Damage to Ligament(s)	1	1
Impaired Healing	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