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

Catalog Number 5407FA2000

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Twenty-five events were reported for this quarter.Twenty-two devices were received for evaluation; twenty events were confirmed during testing.Twenty devices were found to be bent.The reported event was not confirmed for 2 devices; the devices were found to be within specifications for the reported event.Three devices are available for evaluation but have not yet been received.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 25 malfunction events in which the device was bent.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.3 previously reported events are included in this follow-up record.  product return status: 2 devices were received for evaluation.1 device was not available to stryker for evaluation.  evaluation status: 2 reported events were confirmed during testing.- 2 devices were found to be bent.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.

Event Description

This report summarizes 25 malfunction events in which the device was bent.24 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

• 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: 7219786
• MDR Text Key: 98519187
• Report Number: 0001811755-2018-00252
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 25
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• 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: 09/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1