MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 18 INCH CORD "; SAW, POWERED, AND ACCESSORIES

Catalog Number 0848000000

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation.

Event Description

It was reported that during testing conducted at the user facility the device began smoking.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.

Event Description

It was reported that during testing conducted at the user facility, the device began smoking.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: CAST CUTTER, 18 INCH CORD "
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5134879
• MDR Text Key: 27783950
• Report Number: 0001811755-2015-03675
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0848000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1