MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STERNUM BLADE GUARD; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4107008000

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that the sternum blade guard was bent at user facility.The user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

The reported event, blade guard is bent, was confirmed by the technician.The technician found that the blade guard was bent, a bent blade guard can be caused by improper use including using excessive lateral force during operation.Based on the past data, this type of malfunction for this product has not caused or contributed to a death or serious injury.This report was sent in error.

Event Description

It was reported that the sternum blade guard was bent at user facility.The user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

The device has not been received at the manufacturer for testing. an evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that the sternum blade guard was bent at user facility.The user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

This correction is being filed to update the type of reportable event.

• Brand Name: STERNUM BLADE GUARD
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 4279784
• MDR Text Key: 5289469
• Report Number: 0001811755-2014-04295
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2020

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: Health Professional
• Device Catalogue Number: 4107008000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided; 11/28/2020
• Supplement Dates FDA Received: 12/29/2014; 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1