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 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 no patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).One event was reported for this quarter.One device was received.The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.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 no patient involvement; no patient impact.

• 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
• 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: 6980556
• MDR Text Key: 91198002
• Report Number: 0001811755-2017-02048
• 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: 5100015270
• 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