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

Catalog Number 5100015250

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Reported events: ten events were reported for this quarter.Product return status: nine devices were received for evaluation.One devices were available for evaluation but have not yet been received.Evaluation status: four events were confirmed during testing -four devices were found to be affected by detached or missing pieces.Five device evaluations are in progress.Product disposition: these devices are not repairable and were not returned to the user facility.Additional information: there were no remedial actions taken on this device.This device is not labeled for single-use.

Event Description

This report summarizes 10 malfunction events in which the device had a component detach.Ten events had no 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: 6 previously reported events are included in this follow-up record.  product return status 1 device was available for evaluation but has not yet been received.  evaluation status 2 reported events were confirmed during testing.-  2 devices were found to be affected by detached coupler component(s) and compression spring.3 device evaluations are in progress.Additional information 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.

Event Description

This report summarizes 10 malfunction events in which the device had a component detach.10 events had no 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: 10 events were initially reported.10 previously reported events are included in this follow-up record.  product return status 9 devices were received.1 device was not available for evaluation.  evaluation status 8 reported events were confirmed during testing.- 2 devices were found to be affected by a missing compression spring and coupler components.- 1 device was found to be affected by a missing coupler pin, coupler cover and compression spring.- 4 devices were found to be affected by the nose cone separated from the housing.- 1 device was found to be affected by a missing coupler pin.1 reported event was not confirmed during testing.Additional information 10 devices were not labeled for single-use.10 devices were not reprocessed and reused.

Event Description

This report summarizes 10 malfunction events in which the device had a component detach.10 events had no patient involvement; no 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
• MDR Report Key: 7714801
• MDR Text Key: 115210297
• Report Number: 0001811755-2018-01220
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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: E2015055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1