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

Catalog Number 0940000000

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

Patient Problem Abrasion (1689)

Event Date 09/21/2015

Event Type  Malfunction  

Manufacturer Narrative

The device has been received at the manufacturer for testing. An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that a patient was cut while during a cast-removal procedure at the user facility. Additional information regarding any treatment the patient required due to the event have been requested. If additional information regarding the event becomes available, it will be included in a follow-up report.

• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5161807
• MDR Text Key: 28752743
• Report Number: 0001811755-2015-03848
• 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

• Type of Report: Initial
• Report Date: 09/22/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/20/2015
• 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?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/25/2015

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse