MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 230V CAST CUTTER SAW, POWERED, AND ACCESSORIES

Catalog Number 0941000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 09/01/2015

Event Type  Malfunction  

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 at the user facility the device scratched a patient and cut a user. No medical intervention was required, no scar, and no infection were reported with this event.

Event Description

It was reported that during a procedure at the user facility that the device scratched a patient and cut a user. The scratch and cut were treated with a warm compress. The procedure was completed successfully without a clinically significant delay. No additional medical intervention was reported as a result of the event.

• Brand Name: 230V 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5134891
• MDR Text Key: 27784215
• Report Number: 0001811755-2015-03674
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/10/2015

1 Device Was Involved in the Event

0 PatientS WERE 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: 0941000000
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse