MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL

Catalog Number 5100015252

Device Problem Overheating of Device (1437)

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 - 6 events were reported for this quarter.Product return status - 6 devices were received for evaluation.Evaluation status - 2 events were confirmed during testing.1 device was found to be affected by a lubrication problem.1 device was found to be affected by a nose tip separated from housing.4 device evaluations are in progress.Additional information - 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.

Event Description

This report summarizes 6 malfunction events in which the device reportedly overheated.6 events had 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: 6 total events were initially reported.4 previously reported events are included in this follow-up record.  product return status 4 devices were received.  evaluation status 4 reported events were confirmed during testing.- 2 devices were found to be affected by corroded bearings.- 2 devices were found to be affected by lubrication problem.  additional information 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.

Event Description

This report summarizes 6 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.

• Brand Name: MICRO DRILL SERIES ANGLED ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8014003
• MDR Text Key: 125434926
• Report Number: 0001811755-2018-01871
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540391803
• UDI-Public: 04546540391803
• Combination Product (y/n): N
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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: 5100015252
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1