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

Model Number 5100015250

Device Problems Corroded (1131); Overheating of Device (1437)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

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: 6 events were reported for this quarter. Product return status: 1 device was received. 5 device investigation types have not yet been determined. Event confirmation status: 1 reported event was not confirmed. Evaluation results: 1 device was found to be affected by a corroded bearing. Additional information: 6 devices were not labeled for single-use. 6 devices were not reprocessed or reused.

Event Description

This report summarizes 6 malfunction events in which the device reportedly overheated. 6 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 10748372
• MDR Text Key: 213465744
• Report Number: 0001811755-2020-02844
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 5100015250
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse