MAUDE Adverse Event Report: STRYKER INSTRUMENTS SAGITTAL SAW; PERIOPERATIVE SAGITTAL SAW

Model Number 6208

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/25/2018

Event Type  malfunction  

Event Description

During a total knee procedure, doctor was using a system 6 saw.The saw trigger housing and inside pins completely fell apart and onto the sterile field.The broken saw was removed from the field.The field was draped with ioban and microcyn was given to the field for irrigation of wound.

• Brand Name: SAGITTAL SAW
• Type of Device: PERIOPERATIVE SAGITTAL SAW
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 7776406
• MDR Text Key: 116886700
• Report Number: 7776406
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2018
• Date Report to Manufacturer: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA