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

Catalog Number 0940000000

Device Problem Overheating of Device (1437)

Patient Problem Abrasion (1689)

Event Date 03/17/2017

Event Type  malfunction  

Event Description

It was reported that during a procedure at the user facility that the device became warm during use.The patient reported red marks as a result of the device warming up; however, the customer verified that the patient did not receive medical treatment as a result of the event and, while there were red marks on the patient, there was no medically diagnosed burn.No medical intervention was administered as a result of the event.

Manufacturer Narrative

The reported event was not duplicated.

Event Description

It was reported that during a procedure at the user facility that the device became warm during use.The patient reported red marks as a result of the device warming up; however, the customer verified that the patient did not receive medical treatment as a result of the event and, while there were red marks on the patient, there was no medically diagnosed burn.No medical intervention was administered as a result of the event.

• Brand Name: CAST CUTTER
• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6536346
• MDR Text Key: 74177677
• Report Number: 0001811755-2017-01209
• 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
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: 0940000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2011
• 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