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 No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 15 events were reported for this quarter. Product return status: 11 devices were received. 1 device was not available for evaluation. 3 device investigation types have not yet been determined.   event confirmation status: 5 reported events were confirmed; the cause traced to component failure. 5 reported events were not confirmed. 1 device evaluation is still in progress. Evaluation results: 4 devices were found to be affected by internal component corrosion. 2 devices were found to be affected by worn internal components. 1 device was found to be affected by lubrication breakdown. 3 devices were found to be affected by components covered in debris. 1 device was found to be affected by shattered bearings. Additional information: 15 devices were not labeled for single-use. 15 devices were not reprocessed and reused.

Event Description

This report summarizes 15 malfunction events in which the device reportedly overheated. 12 events had no patient involvement; no patient impact. 1 event had patient involvement; no patient impact. 2 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: 8546243
• MDR Text Key: 143082449
• Report Number: 0001811755-2019-01410
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 15
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 5100015250
• 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: 01/01/2019
• 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