STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 16MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
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Catalog Number 5407FA2000 |
Device Problems
Bent (1059); Flaked (1246); Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One event was reported for this quarter.One device was received for evaluation.One event was confirmed during testing.One device was found to be affected by missing paint chips, corrosion, and was bent.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.
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Event Description
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This report summarizes 1 malfunction event in which the device had missing paint chips, overheated, and was bent.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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