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

Catalog Number 9560100

Device Problems Display or Visual Feedback Problem (1184); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with lumbar canal stenosis; and underwent micro-endoscopic discectomy.Intra-op, tip of the reported product damaged, which narrowed the field of view.No patient complications were reported as a result of this event.

• Brand Name: METRX SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10272758
• MDR Text Key: 199720512
• Report Number: 1030489-2020-00901
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885074210353
• UDI-Public: 00885074210353
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9560100
• Device Lot Number: 1367320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1