Table 8.

RCA for returned devices with device related events.

	Cause Unknown	Modification/Sizing/Mishandling Causing Break	Met specifications	Confirmed for Alleged Malfunction	Product did not Meet Specifications	In Progress
Total Device Issues (n = 29)	6 (23.1)	7 (26.9)	6 (23.1)	4 (15.4)	2 (7.7)	1 (3.8)
Break	4 (66.7)	7 (100)	1 (16.7)	4 (100)	2 (100)	0 (0)
Nonspecific Break	4 (100)	4 (57.1)	0 (0)	0 (0)	2 (100)	0 (0)
Shoe Broke Off	0 (0)	3 (42.9)	0 (0)	1 (25)	0 (0)	0 (0)
Wire Broke from Piston	0 (0)	0 (0)	0 (0)	1 (25)	0 (0)	0 (0)
Shaft Broke from Wire	0 (0)	0 (0)	1 (100)	0 (0)	0 (0)	0 (0)
Shaft Broke Off	0 (0)	0 (0)	0 (0)	2 (50)	0 (0)	0 (0)
Displacement	1 (16.7)	0 (0)	2 (33.3)	0 (0)	0 (0)	0 (0)
Nonspecific Displacement	1 (100)	0 (0)	1 (50)	0 (0)	0 (0)	0 (0)
Extrusion	0 (0)	0 (0)	1 (50)	0 (0)	0 (0)	0 (0)
Incorrect Size or Shape	0 (0)	0 (0)	1 (16.7)	0 (0)	0 (0)	0 (0)
Failure to Crimp	1 (16.7)	0 (0)	0 (0)	0 (0)	0 (0)	1 (100)
Loop of Stapes Open	0 (0)	0 (0)	2 (33.3)	0 (0)	0 (0)	0 (0)