TPLC - Total Product Life Cycle

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Device	wrench
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HXC
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Calibration Problem	187	187
Break	174	176
Device-Device Incompatibility	123	124
Fracture	87	87
Material Deformation	77	77
Naturally Worn	56	56
Crack	22	22
Material Integrity Problem	22	22
Material Twisted/Bent	20	20
Detachment of Device or Device Component	20	20
Unintended Movement	19	19
Mechanical Jam	19	19
Scratched Material	12	12
Mechanical Problem	10	10
Failure to Cut	9	9
Contamination /Decontamination Problem	5	5
Corroded	5	5
Compatibility Problem	4	4
Use of Device Problem	4	4
Structural Problem	4	4
No Apparent Adverse Event	4	4
Degraded	3	3
Illegible Information	3	3
Improper or Incorrect Procedure or Method	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Unstable	1	1
Separation Failure	1	1
Shipping Damage or Problem	1	1
Component Missing	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Handling Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Appropriate Term/Code Not Available	1	1
Connection Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	681	683
Insufficient Information	59	60
Failure of Implant	2	2
Bone Fracture(s)	2	2
No Information	1	1
No Known Impact Or Consequence To Patient	1	1
Foreign Body In Patient	1	1
No Consequences Or Impact To Patient	1	1
Vertebral Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	New Standard Device Inc	II	Jun-21-2022