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

Catalog Number 5100015270

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

(b)(4).Reported events : 8 events were reported for this quarter  .Product return status : 8 devices were received for evaluation.Evaluation status : 5 events were confirmed during testing, - 5 devices were found to be affected by detached/missing components, 3 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 8 malfunction events in which the device had a component detach; 7 events had no patient involvement; no patient impact; 1 event had patient involvement; no patient impact.

Event Description

This report summarizes 8 malfunction events in which the device had a component detach.7 events had no patient involvement; no patient impact.1 event had 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: 3 previously reported events are included in this follow-up record.  evaluation status 2 reported events were confirmed during testing.- 2 devices were found to be affected by missing components.1 device evaluation is in progress.  additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 8 total events were initially reported.8 previously reported events are included in this follow-up record.  product return status 8 devices were received.  evaluation status 8 reported events were confirmed during testing.- 4 devices were found to be affected by nose cone separation from the housing.- 1 device was found to be affected by detached collar.- 1 device was found to be affected by detached preload adapter and wave spring.- 1 device was found to be affected by detached nose tip, preload adaptor, and wave spring.- 1 device was found to be affected by detached device coupler, coupler cover, coupler pin, and compression spring.Additional information 8 devices were not labeled for single-use.8 devices were not reprocessed and reused.

Event Description

This report summarizes 8 malfunction events in which the device had a component detach.7 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

• Brand Name: MD SERIES LONG STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7714820
• MDR Text Key: 115213959
• Report Number: 0001811755-2018-01223
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380289
• UDI-Public: 04546540380289
• Combination Product (y/n): N
• Number of Events Reported: 8
• 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: 5100015270
• 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