TPLC - Total Product Life Cycle

• Device: impactor
• Product Code: HWA
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	1609	1609
2019	1550	1550
2020	1477	1477
2021	2006	2006
2022	2086	2086
2023	2245	2245
2024	931	931

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	8522	8522
Crack	1161	1161
Naturally Worn	869	869
Fracture	707	707
Device-Device Incompatibility	661	661
Material Twisted/Bent	337	337
Material Deformation	200	200
Scratched Material	193	193
Contamination /Decontamination Problem	182	182
Material Integrity Problem	123	123
No Apparent Adverse Event	91	91
Mechanical Jam	83	83
Adverse Event Without Identified Device or Use Problem	72	72
Detachment of Device or Device Component	66	66
Appropriate Term/Code Not Available	55	55
Unintended Movement	53	53
Component Missing	38	38
Loose or Intermittent Connection	37	37
Entrapment of Device	36	36
Illegible Information	31	31
Physical Resistance/Sticking	24	24
Material Discolored	21	21
Device Contamination with Chemical or Other Material	21	21
Failure to Disconnect	20	20
Connection Problem	19	19
Mechanical Problem	17	17
Material Fragmentation	13	13
Device Slipped	12	12
Dull, Blunt	12	12
Difficult to Remove	11	11
Manufacturing, Packaging or Shipping Problem	10	10
Structural Problem	9	9
Use of Device Problem	9	9
Insufficient Information	9	9
Corroded	8	8
Compatibility Problem	7	7
Device Damaged by Another Device	6	6
Off-Label Use	6	6
Fitting Problem	5	5
Disassembly	5	5
Device Reprocessing Problem	5	5
Defective Device	5	5
Device Dislodged or Dislocated	5	5
Deformation Due to Compressive Stress	5	5
Defective Component	4	4
Device Issue	4	4
Flaked	4	4
Improper or Incorrect Procedure or Method	4	4
Material Split, Cut or Torn	4	4
Separation Problem	4	4
Positioning Problem	3	3
Device Damaged Prior to Use	3	3
Material Separation	3	3
Delivered as Unsterile Product	3	3
Degraded	3	3
Bent	3	3
Detachment Of Device Component	2	2
Difficult to Insert	2	2
Material Rupture	2	2
Material Disintegration	2	2
Problem with Sterilization	2	2
Failure to Cut	2	2
Device Difficult to Maintain	2	2
Osseointegration Problem	2	2
Mechanics Altered	2	2
Failure to Clean Adequately	2	2
Missing Information	1	1
Difficult or Delayed Separation	1	1
Device Fell	1	1
Device Handling Problem	1	1
Missing Test Results	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Explosion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Protrusion/Extrusion	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Or Device Fragments Location Unknown	1	1
Blocked Connection	1	1
Activation, Positioning or Separation Problem	1	1
Solder Joint Fracture	1	1
Residue After Decontamination	1	1
Loss of Osseointegration	1	1
Separation Failure	1	1
Unstable	1	1
Product Quality Problem	1	1
Peeled/Delaminated	1	1
Device Difficult to Setup or Prepare	1	1
Disconnection	1	1
Accessory Incompatible	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6965	6965
No Consequences Or Impact To Patient	3980	3980
Insufficient Information	526	526
No Code Available	199	199
No Known Impact Or Consequence To Patient	187	187
Not Applicable	107	107
No Patient Involvement	89	89
No Information	49	49
Foreign Body In Patient	47	47
Device Embedded In Tissue or Plaque	8	8
Unspecified Infection	7	7
Pain	6	6
Injury	4	4
Failure of Implant	4	4
Bone Fracture(s)	3	3
Inadequate Osseointegration	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Musculoskeletal problem	1	1
Osteopenia/ Osteoporosis	1	1
Patient Problem/Medical Problem	1	1
Hematoma	1	1
Thrombosis	1	1
Non-union Bone Fracture	1	1
Joint Disorder	1	1
Reaction	1	1
Needle Stick/Puncture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Enztec Limited	II	Jan-24-2020
2	Exactech, Inc.	II	Jun-30-2023
3	Exactech, Inc.	II	Sep-10-2019
4	XTANT Medical	II	Jul-04-2020
5	Zimmer Biomet, Inc.	II	Feb-14-2018