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

Model Number 9560100

Device Problem Crack (1135)

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

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) via the manufacturer representative regarding an event that occurred during the mel procedure during the treatment of levels l4/5 lcs.It was reported that the instrument cracked, or was damaged.Product has been returned, and its replacement status is unknown.No patient injury / complication is reported.

Manufacturer Narrative

H3: product analysis: it was confirmed that the image is defective and the internal lens may be damaged.H6: result codes and conclusion codes were updated based on analysis result.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.

• Brand Name: METRX(TM) SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10716740
• MDR Text Key: 212461950
• Report Number: 1030489-2020-01462
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K002931
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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: 1497126R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1