TPLC - Total Product Life Cycle

• Device: broach
• Product Code: HTQ
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	2	2
2016	73	73
2017	225	225
2018	433	433
2019	460	460
2020	466	466
2021	550	550
2022	506	506
2023	586	586
2024	169	169

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1279	1279
Break	621	621
Unintended Movement	272	272
Failure to Cut	238	238
Naturally Worn	213	213
Scratched Material	209	209
Material Deformation	205	205
Appropriate Term/Code Not Available	166	166
Loose or Intermittent Connection	133	133
Difficult to Advance	115	115
Material Twisted/Bent	102	102
Adverse Event Without Identified Device or Use Problem	86	86
Connection Problem	83	83
Fracture	80	80
Structural Problem	66	66
Dull, Blunt	51	51
Device Damaged Prior to Use	40	40
Physical Resistance/Sticking	38	38
Mechanical Jam	37	37
Component Missing	35	35
Inadequacy of Device Shape and/or Size	34	34
Material Integrity Problem	33	33
Contamination /Decontamination Problem	33	33
Device Slipped	30	30
Chemical Problem	25	25
No Apparent Adverse Event	25	25
Illegible Information	23	23
Fitting Problem	21	21
Crack	21	21
Bent	20	20
Entrapment of Device	18	18
Difficult to Open or Close	17	17
Insufficient Information	17	17
Mechanical Problem	14	14
Difficult to Remove	13	13
Detachment of Device or Device Component	11	11
Device Dislodged or Dislocated	9	9
Tear, Rip or Hole in Device Packaging	7	7
Defective Device	6	6
Device Contaminated During Manufacture or Shipping	6	6
Device Markings/Labelling Problem	6	6
Positioning Problem	6	6
Device Operates Differently Than Expected	5	5
Difficult to Insert	5	5
Misconnection	4	4
Corroded	4	4
Device Issue	4	4
Off-Label Use	4	4
Device Contamination with Chemical or Other Material	4	4
Incomplete or Inadequate Connection	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Device Damaged by Another Device	3	3
Use of Device Problem	3	3
Failure to Advance	2	2
Disassembly	2	2
Blocked Connection	2	2
Deformation Due to Compressive Stress	2	2
Separation Problem	2	2
Failure to Clean Adequately	1	1
Noise, Audible	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Migration	1	1
Output Problem	1	1
Compatibility Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Material Discolored	1	1
Material Disintegration	1	1
Positioning Failure	1	1
Backflow	1	1
Loss of or Failure to Bond	1	1
Difficult To Position	1	1
Material Frayed	1	1
Dent in Material	1	1
Failure to Disconnect	1	1
Malposition of Device	1	1
Solder Joint Fracture	1	1
Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1611	1611
No Consequences Or Impact To Patient	1204	1204
Insufficient Information	203	203
No Code Available	173	173
No Information	147	147
No Known Impact Or Consequence To Patient	135	135
Not Applicable	77	77
Bone Fracture(s)	40	40
Limb Fracture	21	21
Unspecified Tissue Injury	12	12
Pain	10	10
Joint Dislocation	9	9
Unspecified Infection	8	8
No Patient Involvement	7	7
Joint Laxity	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Foreign Body In Patient	3	3
Loss of Range of Motion	2	2
Hip Fracture	2	2
Fatigue	1	1
Deformity/ Disfigurement	1	1
Inadequate Osseointegration	1	1
Scar Tissue	1	1
Thrombosis/Thrombus	1	1
Foreign Body Reaction	1	1
Fall	1	1
Low Blood Pressure/ Hypotension	1	1
Damage to Ligament(s)	1	1
Nerve Damage	1	1
Device Embedded In Tissue or Plaque	1	1
Distress	1	1
Discomfort	1	1
Physical Asymmetry	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Encore Medical, Lp	II	Jul-05-2011
2	Greatbatch Medical	II	May-09-2017
3	Zimmer Inc.	II	Jul-07-2009
4	Zimmer Inc.	II	May-12-2009