TPLC - Total Product Life Cycle

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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	54	55
Material Fragmentation	12	12
Fracture	10	10
Material Integrity Problem	8	8
Detachment of Device or Device Component	7	7
Material Separation	7	7
Contamination /Decontamination Problem	5	5
Peeled/Delaminated	4	4
Material Erosion	4	4
Compatibility Problem	3	3
Mechanical Problem	3	3
Device Fell	3	3
Material Twisted/Bent	3	3
Appropriate Term/Code Not Available	3	3
Component Missing	2	2
Material Deformation	2	2
Loose or Intermittent Connection	2	2
Device Slipped	1	1
Entrapment of Device	1	2
Unintended Movement	1	1
Separation Failure	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Solder Joint Fracture	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	84	84
Foreign Body In Patient	17	17
Insufficient Information	17	17
No Known Impact Or Consequence To Patient	7	7
No Consequences Or Impact To Patient	5	5
Hemorrhage/Bleeding	3	3
Device Embedded In Tissue or Plaque	3	3
Patient Problem/Medical Problem	2	2
No Code Available	1	2
Nerve Damage	1	2
No Patient Involvement	1	1
Pain	1	2
Unspecified Tissue Injury	1	1
Deformity/ Disfigurement	1	2
Spinal Cord Injury	1	2
Ambulation Difficulties	1	2

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