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 Superficial (First Degree) Burn (2685)

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).17 events were reported for this quarter.15 devices were received for evaluation.9 events were duplicated during testing.The reported event was not duplicated during testing for 2 devices; however, the devices were outside specifications.2 devices were found to be affected by corrosion.2 devices were found to be affected by compromised lubrication.2 devices were found to be affected by debris.2 devices were found to be affected by debris and compromised lubrication.3 devices were found to be affected by debris and corrosion.The reported event was not confirmed for 1 device; the device was found to be within specifications for the reported event.3 device evaluations are in progress.2 devices were not available to stryker for evaluation.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 17 malfunction events in which the device reportedly overheated.14 events had patient involvement; no patient impact.1 event had patient involvement; the patient received a first-degree burn.2 events had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Supplemental rationale: 3 previously reported events are included in this follow-up record.Product return status: 3 devices were received for evaluation.Evaluation status: 2 events were not confirmed during testing; however, the devices were found to be affected by corrosion.1 event was not confirmed during testing; the device was found to be within specifications.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Event Description

This report summarizes 17 malfunction events in which the device reportedly overheated.13 events had no patient involvement; no patient impact.1 event had patient involvement; the patient received a first-degree burn.2 event had patient involvement; no patient impact.1 event had no known patient involvement or patient impact.

• 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: 6980604
• MDR Text Key: 91196880
• Report Number: 0001811755-2017-02049
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 17
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

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: 5100015250
• 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