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 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: 6 events were reported for this quarter.Product return status: 4 devices were received.2 device investigation types have not yet been determined.Event confirmation status: 3 reported events were confirmed; the cause traced to component failure.1 reported event was not confirmed.Evaluation results: 3 devices were found to be affected by detached and missing device components.1 device had no device problem found.Additional information: 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.

Event Description

This report summarizes 6 malfunction events in which the device had a component detach.5 events had no patient involvement; no patient impact.1 event 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: 6 previously reported events are included in this follow-up record.Product return status 6 devices were received.Event confirmation status 5 reported events were confirmed.1 reported event was not confirmed.Evaluation results 5 devices were found to be affected by disassembled and missing components.1 device had no problem found.

Event Description

This report summarizes 6 malfunction events in which the device had a component detach.5 events had no patient involvement; no patient impact.1 event had 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: 8546241
• MDR Text Key: 145024457
• Report Number: 0001811755-2019-01411
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

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?: Yes
• 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: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1