MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 16MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407FA2000

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).Twenty-six events were reported for this quarter.Two devices were available for evaluation but have not yet been received.Twenty-four devices were received for evaluation.Twenty-one events were confirmed during testing.Twenty-one devices were found to be bent.Three events were not confirmed during testing; the devices were found to be within specifications for the reported event.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 26 malfunction events in which the device had a bent foot.Twenty-one events had no patient involvement; no patient impact.Three events had patient involvement; no patient impact.Two events resulted in a healthcare professional receiving a small cut.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.2 previously reported events are included in this follow-up record.  product return status: 2 devices were received for evaluation.Evaluation status: 2 reported events were confirmed during testing.2 devices were found to be bent.  2 devices were not labeled for single-use.2 devices were not reprocessed and reused.

Event Description

This report summarizes 26 malfunction events in which the device had a bent foot.21 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.2 events resulted in a healthcare professional receiving a small cut.

• Brand Name: FOOTED ATTACHMENT 16MM
• 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: 7466941
• MDR Text Key: 107227912
• Report Number: 0001811755-2018-00826
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 26
• 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: 5407FA2000
• 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