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

Model Number 5100015250

Device Problem Fracture (1260)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.1 device was not labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device fractured.1 event had no patient involvement; no patient impact.

Manufacturer Narrative

Supplemental rationale corrected data: b5, h10 1 event was originally reported for this failure mode during the reporting quarter.2 events should have been reported; 1 event was inadvertently excluded.- 2 reported events are included in this follow-up record.Product return status 1 device was received.1 device investigation type has not yet been determined.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device was found to be affected by a damaged collar.Additional information 2 devices were labeled for single-use.2 devices were not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 events had no 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: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.Event confirmation status: 1 reported event was confirmed.1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a damaged collar.1 device was found to be affected by corroded bearings.

Event Description

This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 events had no patient involvement; no patient impact.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10329708
• MDR Text Key: 200625795
• Report Number: 0001811755-2020-01837
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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 Model Number: 5100015250
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 06/30/2020; 06/30/2020
• Supplement Dates FDA Received: 07/31/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1