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

Catalog Number 0940000000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Shock (2072)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was reported that the cast cutter is losing power during a procedure.User felt a shock from the saw.There was no injury or medical intervention needed due to the shock.The procedure was completed with a back up device without a delay.After receiving at manufacturer facility, it was noted that there are bare copper wires exposed on the device.

Manufacturer Narrative

The reported event, device seems to cut out, was duplicated.Through functional and visual inspection, the technician observed that the device had a cut cord with bare wire exposed.The output shaft assembly and hood assembly were stripped and the rocker switch was found to function intermittently, causing the device to hesitate when started.The rocker switch, cord assembly, output shaft assembly, and hood were replaced, along with other suggested components, and the repaired device was returned to the customer after passing the final inspection.

Manufacturer Narrative

The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Event Description

It was reported that the cast cutter is losing power during a procedure.User felt a shock from the saw.There was no injury or medical intervention needed due to the shock.The procedure was completed with a back up device without a delay.After receiving at manufacturer facility, it was noted that there are bare copper wires exposed on the device.

• 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: 4134922
• MDR Text Key: 16176740
• Report Number: 0001811755-2014-03457
• 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: 09/05/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 10/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2009
• 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