TPLC - Total Product Life Cycle

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Device	instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
Product Code	KIJ
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disassembly	19	19
Unintended Power Up	16	16
Device-Device Incompatibility	10	10
Battery Problem	9	9
Overheating of Device	9	9
Smoking	8	8
Unintended Movement	7	7
Fluid/Blood Leak	7	7
Leak/Splash	6	6
Break	5	5
Component Missing	3	3
Device Operates Differently Than Expected	3	3
Delayed Charge Time	3	3
Failure to Shut Off	2	2
Device Dislodged or Dislocated	2	2
Metal Shedding Debris	2	2
Bent	1	1
Unintended System Motion	1	1
Device Inoperable	1	1
Unintended Ejection	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Fracture	1	1
Corroded	1	1
Entrapment of Device	1	1
Insufficient Information	1	1
Device Fell	1	1
Failure to Clean Adequately	1	1
Failure to Fire	1	1
Component Falling	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	53	53
No Known Impact Or Consequence To Patient	17	17
No Clinical Signs, Symptoms or Conditions	12	12
No Information	7	7
No Consequences Or Impact To Patient	4	4
Foreign Body In Patient	2	2
Insufficient Information	2	2
Therapeutic Effects, Unexpected	2	2
Burn, Thermal	1	1
Pain	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Instruments Div. of Stryker Corporation	II	Mar-10-2009