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

Catalog Number 5100015250

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2017

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 available for evaluation but has not yet been received. 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 had a broken cutting accessory still attached. There was patient involvement; no patient impact.

Event Description

This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached. There was patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.     supplemental rationale corrected data: 1 previously reported events are included in this follow-up record.   product return status: 1 device was not available to stryker for evaluation.   additional information: 1 device is not labeled for single-use. 1 device was not reprocessed and reused. Device not returned.

• 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
• MDR Report Key: 7467084
• Report Number: 0001811755-2018-00912
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No