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 Laceration(s) (1946)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

It was reported that during a cast removal at the user facility, the device nicked a patient.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.

Manufacturer Narrative

The device is available for evaluation but has not yet been received.Additional information will be submitted once the device is received and the quality investigation is complete.The device has not been returned for analysis at this time.

Manufacturer Narrative

No failure related to this complaint was found upon device evaluation.Preventative maintenance was performed, and the device was returned to the customer.

Event Description

It was reported that during a cast removal at the user facility the device nicked a patient.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4892691
• MDR Text Key: 6536274
• Report Number: 0001811755-2015-02424
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• 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: 07/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/1992
• 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