MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. METRX ENDOSCOPE; ARTHROSCOPE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

After removing k-wire from patient's incision, the doctor passed a k-wire through metrx tube.Neither the k-wire or the metrx tube was in the patient's incision at this time.When the k-wire was passed through the metrx tube, brown discharge was pushed out of the end of the metrx tube.The tube, k-wire, and metrx tube set were removed from the sterile field and new sterile towels were placed on the field.No patient harm.

• Brand Name: METRX ENDOSCOPE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinnea road; memphis TN 38118
• MDR Report Key: 6085097
• MDR Text Key: 59386711
• Report Number: 6085097
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2016,10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1