STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 16MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
|
Back to Search Results |
|
Catalog Number 5407FA2000 |
Device Problem
Bent (1059)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).9 devices were received for evaluation; 9 events were confirmed during testing.Evaluation found the foot of each of the devices was bent.2 devices were not available to stryker for evaluation.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.
|
|
Event Description
|
This report summarizes 11 malfunction events in which the duraguard foot was found to be bent, which can cause damage to the dura.For 10 events, there was no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|
|
|