MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL

Catalog Number 5100015252

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2018

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: 1 event was reported for this quarter.Product return status: 1 device was received for evaluation.  evaluation status: 1 device evaluation is in progress.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.

Event Description

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

Event Description

This report summarizes 1 malfunction event in which the device reportedly overheated.1 event 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 corrected data: 1 event was initially reported.1 previously reported event is included in this follow-up record.  product return status 1 device was received.Evaluation status 1 reported event was not confirmed during testing.  additional information 1 device is not labeled for single-use.1 device was not reprocessed and reused.

• Brand Name: MICRO DRILL SERIES ANGLED ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8016713
• MDR Text Key: 125657423
• Report Number: 0001811755-2018-02283
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540391803
• UDI-Public: 04546540391803
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100015252
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1