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

Catalog Number 5400050000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Reported events: 2 events were reported for this quarter.Product return status: 1 device was received for evaluation.1 device was available for evaluation but has not yet been received.Evaluation status: 1 event was confirmed during testing.1 device was found to be affected by debris.1 device evaluation is in progress.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.

Event Description

This report summarizes 2 malfunction events in which the device ran without user activation.2 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: 8014634
• MDR Text Key: 125757078
• Report Number: 0001811755-2018-02077
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 07613153011781
• UDI-Public: 07613153011781
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• 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: 06/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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