TPLC - Total Product Life Cycle

show TPLC since

Device	rongeur
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTX
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	56	56
Material Fragmentation	13	13
Fracture	13	13
Material Integrity Problem	9	9
Detachment of Device or Device Component	9	9
Contamination /Decontamination Problem	5	5
Material Separation	5	5
Peeled/Delaminated	4	4
Material Erosion	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Compatibility Problem	3	3
Mechanical Problem	3	3
Material Twisted/Bent	2	2
Material Deformation	2	2
Loose or Intermittent Connection	2	2
Separation Failure	1	1
Device Fell	1	1
Positioning Problem	1	1
Failure to Align	1	1
Structural Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Solder Joint Fracture	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	93
Foreign Body In Patient	23	23
Insufficient Information	18	18
No Known Impact Or Consequence To Patient	16	16
No Consequences Or Impact To Patient	14	14
Hemorrhage/Blood Loss/Bleeding	3	3
Device Embedded In Tissue or Plaque	3	3
Patient Problem/Medical Problem	2	2
Failure of Implant	1	1
No Code Available	1	2
No Information	1	1
Bone Fracture(s)	1	1
Nerve Damage	1	2
Ambulation or Postural Difficulties	1	2
No Patient Involvement	1	1
Pain	1	2
Unspecified Tissue Injury	1	1
Deformity/ Disfigurement	1	2
Spinal Cord Injury	1	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Sklar Instruments	II	Jan-16-2025