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

Catalog Number 5100015270

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Reported events: nine events were reported for this quarter.Product return status: nine devices were received for evaluation.Evaluation status: seven events were confirmed during testing.-one device was found to be affected a mechanical problem.-five devices were found to be affected by corrosion.-one device was found to be affected by a lubrication problem.One event was not confirmed during testing; the device was found to be within specifications.One device evaluation is in progress.         product disposition: this device is not repairable and was not returned to the user facility.Additional information: there were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.Eight events had no patient involvement; no patient impact.One event had patient involvement; the patient received a first-degree burn.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received for evaluation.  evaluation status: 1 reported event was not confirmed during testing; however: 1 device was found to be affected by corrosion.1 device is not labeled for single-use.1 device was not reprocessed and reused.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.8 events had no patient involvement; no patient impact.1 event had patient involvement; the patient received a first-degree burn.

• Brand Name: MD SERIES LONG STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7715521
• MDR Text Key: 115209346
• Report Number: 0001811755-2018-01300
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380289
• UDI-Public: 04546540380289
• Combination Product (y/n): N
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100015270
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1