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

Catalog Number 0940000000

Device Problems Electrical /Electronic Property Problem (1198); Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

It was reported that the cord was cut and bare wires were exposed which could lead to potential shock hazard.It was found at service floor at manufacturer facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that the cord was cut and bare wires were exposed which could lead to potential shock hazard.It was found at service floor at manufacturer facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported event through service, cord is cut with exposed wires, was confirmed.During the inspection the service technician observed that the cord was cut exposing bare wires.The damaged adaptor assembly cord was replaced, device was repaired and 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.

• 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: 3882274
• MDR Text Key: 4567849
• Report Number: 0001811755-2014-02191
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2014

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: Other
• Device Catalogue Number: 0940000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• 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