MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Catalog Number 5100015250

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Seven events were reported for this quarter.Five devices were received for evaluation; 3 events were duplicated during testing.One event was not duplicated during testing; however, the device was out of specifications.One device was found to be affected by corrosion.One device was found to be affected by corrosion and shattered bearings.One device was found to be affected by corrosion and compromised lubrication.One device was found to be affected by compromised lubrication and debris.One device evaluation is in progress.Two devices are available for evaluation but have not yet been received.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 malfunction events in which the device was reportedly overheating.Six events had no patient involvement; no patient impact.One event had patient involvement or patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Supplemental rationale: 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; the devices were found to be within specifications.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Event Description

This report summarizes 7 malfunction events in which the device was reportedly overheating.6 events had no patient involvement; no patient impact.1 event had patient involvement or patient impact.

• Brand Name: MICRODRILL SERIES STRAIGHT ATTACHMENT
• 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: 7219274
• MDR Text Key: 98433837
• Report Number: 0001811755-2018-00087
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 7
• 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: 5100015250
• 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