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.

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.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale 15 previously reported events are included in this follow-up record.  product return status 13 devices were received.2 devices were not available for evaluation.  event confirmation status 5 reported events were confirmed.8 reported events were not confirmed.Evaluation results 5 devices were found to be affected by internal component corrosion.2 devices were found to be affected by worn components.1 device was found to be affected by lubrication breakdown.4 devices were found to be affected by debris.1 device was found to be affected by shattered bearings.

• 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: 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
• Number of Events Reported: 15
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/01/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 01/01/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1