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 12/25/2018

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: 20 events were reported for this quarter.  product return status: 17 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.  evaluation status: confirmed.10 reported events were confirmed during testing.4 devices were found to be affected by corrosion.1 device was found to be affected by shattered bearings.2 devices were found to be affected by corrosion and debris.2 devices were found to be affected by lubrication breakdown.1 device was found to be affected corrosion, debris, and shattered bearings.Not confirmed: 5 reported events were not confirmed during testing; however: 2 devices were found to be affected by corrosion.1 device was found to be affected by corrosion and debris.1 device was found to be affected by debris.1 device was found to be affected by shattered bearings.1 reported event was not confirmed during testing.In progress: 1 device evaluations are in progress.Additional information: 20 devices were not labeled for single-use.20 devices were not reprocessed and reused.

Event Description

This report summarizes 20 malfunction events in which the device reportedly overheated.18 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event had the patient receive a burn.

Event Description

This report summarizes 20 malfunction events in which the device reportedly overheated.18 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event had the patient receive a burn.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: 20 previously reported events are included in this follow-up record.Product return status 17 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status 10 reported events were confirmed; the cause was traced to component failure.7 reported events were not confirmed.Evaluation results 6 devices were found to be affected by corrosion.2 devices were found to be affected by lubrication breakdown.3 device was found to be affected by corrosion and debris.2 device was found to be affected by and debris.2 devices were found to be affected by shattered bearings.1 device was found to be affected corrosion, debris, and shattered bearings.1 device had no problem found.

• 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: 8284966
• MDR Text Key: 134512035
• Report Number: 0001811755-2019-00310
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 4546540380272
• Combination Product (y/n): N
• Number of Events Reported: 20
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1