MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO OSCILLATING SAW; UNIT, OPERATIVE DENTAL

Catalog Number 5100031000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One event was reported for this quarter.One device was available for evaluation but has not yet been received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

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

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale.Corrected data: 1 previously reported event is included in this follow-up record.Product return status: 1 device was not available to stryker for evaluation. additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.Device not received for evaluation.

Event Description

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

• Brand Name: TPS MICRO OSCILLATING SAW
• 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: 6980599
• MDR Text Key: 91256244
• Report Number: 0001811755-2017-02082
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5100031000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1