MAUDE Adverse Event Report: STRYKER INSTRUMENTS SYSTEM 6; SAW, SAGITTAL BLADE

Model Number 6208

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/05/2014

Event Type  No Answer Provided  

Event Description

Doctor was using stryker system 6 sagittal saw and as he was bearing down on it to make the cut, the system fell apart in the patient.There were pieces of the device in the wound along with some lubricant that normally is not exposed to the patient.

• Brand Name: SYSTEM 6
• Type of Device: SAW, SAGITTAL BLADE
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave; kalamazoo MI 49001
• MDR Report Key: 3652644
• MDR Text Key: 16011562
• Report Number: 3652644
• Device Sequence Number: 1
• Product Code: HSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Device Model Number: 6208
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 140