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 Consequences Or Impact To Patient (2199)

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 : 4 events were reported for this quarter.Product return status: 4 devices were received.Evaluation status : confirmed, 3 reported events were confirmed during testing; 3 devices were found to be affected by component detachment.In progress: 1 device evaluation is in progress.  additional information: 4 devices were not labeled for single-use, 4 devices were not reprocessed and reused.

Event Description

This report summarizes 4 malfunction events in which the device had a component detach, 2 events 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: 4 previously reported events are included in this follow-up record.  product return status 4 devices were received.  event confirmation status 4 reported events were confirmed; the cause traced to component failure.Evaluation results 4 devices were found to be affected by a mechanical problem.

Event Description

This report summarizes 4 malfunction events in which the device had a component detach.2 events had no patient involvement; no patient impact.2 events 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: 8284980
• MDR Text Key: 134460849
• Report Number: 0001811755-2019-00306
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380289
• UDI-Public: 4546540380289
• Combination Product (y/n): N
• Number of Events Reported: 4
• 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: 5100015270
• 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