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

Model Number 9560100

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received from healthcare provider via service and repair regarding an event happened during intra-op of the reported product.The procedure performed was mentioned as med.It was reported that, the scope was cloudy and cannot be seen.There was a patient involved during this event and the reported product came in contact with patient.There was no health damage in patient reported as result.There was a delay of few minutes reported when replacing the device.There were no further complications reported regarding the event.

Manufacturer Narrative

Product analysis of part#9560100 ; lot#1605903r analysis summary: as per the service, it was found that the image was cloudy, there were scratches around the outer tube and the tip part of lens.Root cause was unknown.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12826423
• MDR Text Key: 283313795
• Report Number: 1030489-2021-01409
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2021

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: Health Professional
• Device Model Number: 9560100
• Device Catalogue Number: 9560100
• Device Lot Number: 1605903R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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