TPLC - Total Product Life Cycle

• Device: broach
• Regulation Description: Orthopedic manual surgical instrument.
• Product Code: HTQ
• Regulation Number: 888.4540
• Device Class: 1

Device Problems
Break	197
Appropriate Term/Code Not Available	148
Device-Device Incompatibility	127
Loose or Intermittent Connection	87
Scratched Material	75
Naturally Worn	71
Connection Problem	65
Material Deformation	42
Component Missing	33
Fracture	27
Bent	20
Fitting Problem	20
Insufficient Information	17
Material Twisted / Bent	16
Crack	13
Mechanical Problem	13
Physical Resistance / Sticking	11
Inadequacy of Device Shape and/or Size	8
Mechanical Jam	7
Unintended Movement	6
Difficult to Remove	6
Adverse Event Without Identified Device or Use Problem	5
Difficult to Insert	5
Positioning Problem	4
Device Slipped	4
Incomplete or Inadequate Connection	4
Device Issue	4
Misconnection	4
Dull, Blunt	3
Entrapment of Device	3
Device Damaged Prior to Use	2
Defective Device	2
Blocked Connection	2
Separation Problem	2
Deformation Due to Compressive Stress	2
Disassembly	2
Loss of or Failure to Bond	1
Difficult to Open or Close	1
Solder Joint Fracture	1
Failure to Advance	1
Compatibility Problem	1
Material Integrity Problem	1
Material Disintegration	1
Detachment of Device or device Component	1
Difficult To Position	1
Failure to Disconnect	1
Manufacturing, Packaging or Shipping Problem	1
Loosening of Implant Not Related to Bone-Ingrowth	1
Failure to Clean Adequately	1
Total Device Problems	1070

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