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

Catalog Number 5100015272

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).1 event was reported for this quarter.1 device was received; 1 device evaluation is in progress.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 1 malfunction event in which the device reportedly overheated.There was patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, (b)(4).1 event was reported for this quarter.1 device was received; however, the condition in which the device was received, the device could not be functionally tested.While the event was not duplicated; the device was found to contain debris.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 1 malfunction event in which the device reportedly overheated.There was patient involvement; no patient impact.

• Brand Name: MD SERIES LONG ANGLED 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6980565
• MDR Text Key: 91087799
• Report Number: 0001811755-2017-02047
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100015272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• 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