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
Overheating of Device	9	9
Battery Problem	9	9
Smoking	8	8
Fluid/Blood Leak	7	7
Unintended Movement	7	7
Leak/Splash	6	6
Break	4	4
Delayed Charge Time	3	3
Component Missing	3	3
Device Operates Differently Than Expected	3	3
Metal Shedding Debris	2	2
Device Dislodged or Dislocated	2	2
Failure to Shut Off	2	2
Insufficient Information	1	1
Entrapment of Device	1	1
Component Falling	1	1
Failure to Clean Adequately	1	1
Detachment Of Device Component	1	1
Unintended Ejection	1	1
Unintended System Motion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Bent	1	1
Fracture	1	1
Device Fell	1	1
Failure to Fire	1	1
Device Inoperable	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	11	11
No Information	7	7
No Consequences Or Impact To Patient	4	4
Therapeutic Effects, Unexpected	2	2
Foreign Body In Patient	2	2
Device Embedded In Tissue or Plaque	1	1
Pain	1	1
Burn, Thermal	1	1
Insufficient Information	1	1

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