MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE POWERED INSTRUMENT DRIVER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number 5400050000

Device Problem Device Remains Activated (1525)

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

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported events : 2 events were reported for this quarter.Product return status: 1 device was received for evaluation, 1 device was available for evaluation but has not yet been received.Evaluation status: 1 event was not confirmed during testing; the device was found to be within specifications.Product disposition: 1 device was repaired and returned to the account.Additional information: there were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 2 malfunction events in which the device had run-on; 2 events had no patient involvement; no patient impact.

Event Description

This report summarizes 2 malfunction events in which the device had run-on.2 events had 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: 2 total events were initially reported.1 previously reported event is included in this follow-up record.  product return status 1 device was not available for evaluation.  additional information 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.H3 other text : device not returned.

• Brand Name: CORE POWERED INSTRUMENT DRIVER
• Type of Device: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7715275
• MDR Text Key: 115200482
• Report Number: 0001811755-2018-01362
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 07613153011781
• UDI-Public: 07613153011781
• 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
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5400050000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1