MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE POWERED INSTRUMENT DRIVER; UNIT, OPERATIVE DENTAL

Catalog Number 5400050000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).3 events were reported for this quarter.2 devices were received for evaluation.1 device was available for evaluation but has not yet been received.1 event was not confirmed during testing; the device was found to be within specifications.1 device evaluation is in progress.1 device was repaired and returned to the account.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.There was no patient involvement; no patient impact.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.There was no patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.  supplemental rationale corrected data: 2 previously reported events are included in this follow-up record.  product return status 1 device was received for evaluation.1 device was not available to stryker for evaluation.  evaluation status 1 reported event was not confirmed during testing; however: - 1 device was found to be affected by crossed wires.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.

• Brand Name: CORE POWERED INSTRUMENT DRIVER
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7467104
• MDR Text Key: 106970891
• Report Number: 0001811755-2018-00882
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5400050000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1