TPLC - Total Product Life Cycle

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Device	tap, bone
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWX
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	220	221
Device-Device Incompatibility	146	146
Contamination /Decontamination Problem	51	51
Fracture	38	40
Material Deformation	29	29
Failure to Cut	21	21
Entrapment of Device	11	11
Material Separation	11	11
Appropriate Term/Code Not Available	9	9
Crack	8	8
Material Integrity Problem	8	8
Material Twisted/Bent	7	7
Mechanical Jam	6	6
Material Fragmentation	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Detachment of Device or Device Component	5	5
Mechanical Problem	4	4
Material Split, Cut or Torn	3	3
Difficult to Remove	3	3
Use of Device Problem	2	2
No Apparent Adverse Event	2	2
Naturally Worn	2	2
Corroded	2	2
Device Slipped	1	1
Fitting Problem	1	1
Expulsion	1	1
Device Contaminated During Manufacture or Shipping	1	1
Separation Failure	1	1
Degraded	1	1
Mechanics Altered	1	1
Illegible Information	1	1
Flaked	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	472	475
Insufficient Information	29	29
Foreign Body In Patient	28	28
Bone Fracture(s)	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Device Embedded In Tissue or Plaque	2	2
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Infiltration into Tissue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Synthes (USA) Products LLC	II	Mar-30-2026