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

Model Number 9560101

Device Problems Loose or Intermittent Connection (1371); Poor Quality Image (1408); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: information was received from a healthcare facility via manufacturer representative regarding a endoscope device used for spinal therapy.It was reported that on an unknown date, intra-op, there was poor visibility of the product.No further information available.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare facility via manufacturer representative regarding a endoscope device used for spinal therapy.It was reported that on an unknown date, intra-op, there was poor visibility of the product.No further information available.There were no further complications reported regarding the event.

Manufacturer Narrative

H3: product analysis: analysis confirmed that the lens was broken and the tip and outer tube had a scratch and were damaged, also the welded region had a crack.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Update: this event was created based on repair request received by the japan service and repair group.The instrument came in contact with the patient.There was no impact to the patient.Procedure involved : endoscopic discectomy pre-operative diagnosis: hernia the image was dark.There were scratches and dent that covered the glass and outer tube.The movement of the coupler was too loose.

• Brand Name: METRX II
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10293393
• MDR Text Key: 199719103
• Report Number: 1030489-2020-00930
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K993021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

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: 9560101
• Device Catalogue Number: 9560101
• Device Lot Number: 1175369R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/18/2020
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1