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 Burn, Thermal (2530)

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: 36 events were reported for this quarter. Product return status: 35 devices were received for evaluation. 1 device was available for evaluation but has not yet been received. Evaluation status: 24 events were confirmed during testing. 16 devices were found to be affected by corrosion. 4 devices were found to be affected by worn components. 2 devices were found to be affected by worn components and corrosion. 2 devices were found to be affected by shattered bearings. 3 events were not confirmed during testing; however: 1 device was found to be affected by corrosion and debris. 2 devices were found to be affected by corrosion. 8 device evaluations are in progress. Additional information: 36 devices were not labeled for single-use. 36 devices were not reprocessed and reused.

Event Description

This report summarizes 36 malfunction events in which the device reportedly overheated. 31 events had no patient involvement; no patient impact. 1 event had no known patient involvement or patient impact. 1 event had patient involvement; no patient impact. 3 events had the patient receive a burn.

• 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: 8014870
• MDR Text Key: 125492449
• Report Number: 0001811755-2018-02113
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 36
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

0 Patients were 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

• Device Catalogue Number: 5100015250
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/02/2018
• 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