MAUDE Adverse Event Report: STRYKER INSTRUMENTS; STERNAL SAW

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

The surgical resident was using the saw and trying to turn the saw rather acutely to cut in a curving fashion but turned too quickly which led to the blade breaking.There was no harm to the patient and the broken piece immediately removed from the field.Http://www.Stryker.Com/stellent/groups/public/documents/web_prod/007117.Pdf.This is the company brochure for this product.
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manufacturer response for stryker sternal saw, (brand not provided) (per site reporter).
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the operating room (or) contacted the manufacturer representative and the saw and drill were provided to the representative for the company to review.The company has all of the identifying information, so no lot number or drill number is available.

• Type of Device: STERNAL SAW
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 3940481
• MDR Text Key: 4573538
• Report Number: 3940481
• 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
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR