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

Catalog Number 5100015250

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/01/2018

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 - 3 events were reported for this quarter.Product return status - 3 devices were received for evaluation.  evaluation status - 3 device evaluations are in progress.Additional information - 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.1 event had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.1 event had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.

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: h10 3 total events were initially reported.3 previously reported events are included in this follow-up record.  product return status 3 devices were received.  evaluation status confirmed 1 reported event was confirmed during testing.- 1 device was found to be affected by compromised lubrication.Not confirmed 1 reported event was not confirmed during testing; however: - 1 device was found to be affected by internal corrosion.1 reported event was not confirmed during testing.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

• 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: 8014691
• MDR Text Key: 125460273
• Report Number: 0001811755-2018-02099
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• 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: 09/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1