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

Catalog Number 5100031000

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).1 devices is available for evaluation but has not yet been evaluated.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 was reportedly smoking.There was no patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).One device was received for evaluation; the reported event was confirmed.Investigation found that the device was affected by worn and damaged internal components.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 was reportedly smoking.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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6280756
• MDR Text Key: 66131309
• Report Number: 0001811755-2017-00424
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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: 09/01/2016
• 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
• Patient Sequence Number: 1