MAUDE Adverse Event Report: STYKER INSTRUMENTS, INSTRUMENTS DIVISION CORE BLADE; SAW, ELECTRICALLY POWERED

Catalog Number 5400-134-283

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2013

Event Type  malfunction  

Event Description

Saw blade broke during use on the sternum - stryker blade.Md note: during the division of the sternum, the saw blade of the stryker saw broke.Chest x-ray obtained at the end of the operation, with no fragment.

• Brand Name: CORE BLADE
• Type of Device: SAW, ELECTRICALLY POWERED
• Manufacturer (Section D): STYKER INSTRUMENTS, INSTRUMENTS DIVISION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 3687299
• MDR Text Key: 4296551
• Report Number: 3687299
• Device Sequence Number: 1
• Product Code: DWI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5400-134-283
• Device Lot Number: 317030112083017K4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2014
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 94