MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELITE 7CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407120450

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).1 event was reported for this quarter.1 device was received for evaluation.1 device evaluation is in progress.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 leaking.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 received for evaluation.  evaluation status: 1 reported event was not confirmed during testing; the device was found to be within specifications.  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 was leaking.There was no patient involvement; no patient impact.

• Brand Name: ELITE 7CM STRAIGHT ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7466983
• MDR Text Key: 107226929
• Report Number: 0001811755-2018-00760
• Device Sequence Number: 1
• Product Code: HBE
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5407120450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2017
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 12/02/2017
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1