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

Model Number 9560101

Device Problem Optical Problem (3001)

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

Event Date 09/26/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis summary: ¿the scope is so dark and difficult to see¿ was confirmed.It was confirmed that the inner cylinder of the coupler had come off and that the outer tube had scratches and dents.The root cause was unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from healthcare provider via service and repair regarding an event happened during med procedure.The pre-op diagnosis was mentioned as hernia.It was reported that, the scope was so dark and difficult to see.The reported product came in contact with patient but there was no health impact shown.There was no time delay in procedure reported as a result.There were no symptoms or complications to patient or physician reported as a result of this event.No further complications reported.

Manufacturer Narrative

H3: product analysis of part#9560101, lot#597153 analysis summary: service report confirmed that the amount of light was low and the image was dark, that the coupler's inner cylinder was misaligned, and that there was a scratch/dent in the outer tube.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 II
• 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: 12710599
• MDR Text Key: 278760652
• Report Number: 1030489-2021-01326
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00673978085456
• UDI-Public: 00673978085456
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 597153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1