This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.12 devices were evaluated in the field and the issue was confirmed; 6 devices had broken/damaged components, 3 devices had electrical shorts, and 3 devices had worn components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
|