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 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This report summarizes 4 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.2 events had no known patient involvement; no known patient impact; attempts are being made for additional information.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale: corrected data: 3 previously reported events are included in this follow-up record.  product return status: 2 devices were received for evaluation.1 device was not available to stryker for evaluation.Evaluation status: 2 events were not confirmed during testing; however: - 1 device was found to be affected by electrical interference.- 1 device was found to be affected by a faulty handpiece interface connector.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Event Description

This report summarizes 4 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7219521
• MDR Text Key: 98523445
• Report Number: 0001811755-2018-00175
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1