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	219	219
Break	176	176
Device-Device Incompatibility	114	114
Fracture	95	95
Naturally Worn	58	58
Material Deformation	50	50
Material Integrity Problem	28	28
Material Twisted/Bent	24	24
Mechanical Problem	23	23
Detachment of Device or Device Component	18	18
Mechanical Jam	15	15
Corroded	14	14
Crack	13	13
Scratched Material	12	12
Unintended Movement	10	10
Failure to Cut	9	9
No Apparent Adverse Event	4	4
Component Missing	4	4
Use of Device Problem	4	4
Contamination /Decontamination Problem	4	4
Compatibility Problem	4	4
Degraded	3	3
Structural Problem	3	3
Illegible Information	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Separation Failure	2	2
Physical Resistance/Sticking	2	2
Failure to Calibrate	2	2
Appropriate Term/Code Not Available	2	2
Improper or Incorrect Procedure or Method	2	2
Unstable	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Advance	1	1
Packaging Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Accessory Incompatible	1	1
Activation Failure	1	1
Connection Problem	1	1
Activation, Positioning or Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	600	600
No Consequences Or Impact To Patient	66	66
Insufficient Information	57	57
No Patient Involvement	31	31
No Known Impact Or Consequence To Patient	13	13
No Code Available	10	10
Foreign Body In Patient	5	5
No Information	4	4
Failure of Implant	2	2
Patient Problem/Medical Problem	1	1
Not Applicable	1	1
Vertebral Fracture	1	1
Device Embedded In Tissue or Plaque	1	1

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