MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 12MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407FA1000

Device Problem Bent (1059)

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).11 events were reported for this quarter.1 device was available for evaluation but has not yet been received.9 devices were received for evaluation.1 device visually inspected at the account.4 events were not confirmed during testing; the devices were found to be within specifications.6 events were confirmed during testing.6 devices were found to be bent.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 11 malfunction events in which the device was bent.11 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

Event Description

This report summarizes 11 malfunction events in which the device was bent.

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 confirmed during testing.- 1 device was found to be bent.  additional information 1 device is not labeled for single-use.1 device was not reprocessed and reused.

• Brand Name: FOOTED ATTACHMENT 12MM
• 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: 7466918
• MDR Text Key: 106967982
• Report Number: 0001811755-2018-00853
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 11
• 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

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5407FA1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1