TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
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	135	135

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1260	1260
Break	617	617
Unintended Movement	268	268
Failure to Cut	238	238
Naturally Worn	209	209
Scratched Material	207	207
Material Deformation	202	202
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	84	84
Connection Problem	83	83
Fracture	80	80
Structural Problem	64	64
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
Contamination /Decontamination Problem	33	33
Material Integrity Problem	30	30
Device Slipped	30	30
Chemical Problem	25	25
No Apparent Adverse Event	25	25
Illegible Information	23	23
Crack	21	21
Fitting Problem	21	21
Bent	20	20
Entrapment of Device	18	18
Difficult to Open or Close	17	17
Insufficient Information	16	16
Mechanical Problem	14	14
Difficult to Remove	13	13
Detachment of Device or Device Component	10	10
Device Dislodged or Dislocated	8	8
Tear, Rip or Hole in Device Packaging	6	6
Defective Device	6	6
Positioning Problem	6	6
Device Markings/Labelling Problem	6	6
Difficult to Insert	5	5
Device Contaminated During Manufacture or Shipping	5	5
Device Operates Differently Than Expected	5	5
Corroded	4	4
Misconnection	4	4
Incomplete or Inadequate Connection	4	4
Device Contamination with Chemical or Other Material	4	4
Device Issue	4	4
Off-Label Use	4	4
Device Damaged by Another Device	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Use of Device Problem	3	3
Disassembly	2	2
Deformation Due to Compressive Stress	2	2
Failure to Advance	2	2
Separation Problem	2	2
Blocked Connection	2	2
Difficult to Open or Remove Packaging Material	1	1
Output Problem	1	1
Noise, Audible	1	1
Difficult To Position	1	1
Failure to Disconnect	1	1
Positioning Failure	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Dent in Material	1	1
Failure to Clean Adequately	1	1
Sticking	1	1
Material Discolored	1	1
Solder Joint Fracture	1	1
Migration	1	1
Compatibility Problem	1	1
Material Disintegration	1	1
Loss of or Failure to Bond	1	1
Backflow	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1585	1585
No Consequences Or Impact To Patient	1204	1204
Insufficient Information	195	195
No Code Available	173	173
No Information	147	147
No Known Impact Or Consequence To Patient	134	134
Not Applicable	77	77
Bone Fracture(s)	39	39
Limb Fracture	20	20
Unspecified Tissue Injury	12	12
Pain	10	10
Unspecified Infection	8	8
Joint Dislocation	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
Hip Fracture	2	2
Loss of Range of Motion	2	2
Scar Tissue	1	1
Damage to Ligament(s)	1	1
Nerve Damage	1	1
Low Blood Pressure/ Hypotension	1	1
Fall	1	1
Fatigue	1	1
Foreign Body Reaction	1	1
Deformity/ Disfigurement	1	1
Distress	1	1
Discomfort	1	1
Inadequate Osseointegration	1	1
Device Embedded In Tissue or Plaque	1	1
Thrombosis/Thrombus	1	1
Physical Asymmetry	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Greatbatch Medical	II	May-09-2017