MAUDE Adverse Event Report: SEGWAY ORTHOPAEDICS; KNIFE, ORTHOPEDIC

Model Number 200-1003

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

While using the segway retrograde ligament knife, the end broke off inside the patient's right foot.Using a scope and flouroscopy, it was determined that all pieces were retrieved from the patient's foot.

• Type of Device: KNIFE, ORTHOPEDIC
• Manufacturer (Section D): SEGWAY ORTHOPAEDICS; 5205 avenida encinas ste c; carlsbad CA 92008
• MDR Report Key: 3943337
• MDR Text Key: 4603480
• Report Number: 3943337
• Device Sequence Number: 1
• Product Code: HTS
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 200-1003
• Device Lot Number: 1061401
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR