MAUDE Adverse Event Report: MSD BARTLETT MFG METRX SYSTEM; ARTHROSCOPE

Model Number	9560100
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from an healthcare provider via manufacturer representative regarding a product used for micro endoscopic discectomy (med) spinal therapy for lumbar disc herniation.It was reported that the image was cloudy.There were no further complications or symptoms reported regarding the event.Additional information was received via manufacturer representative that the image appeared blurred.
Additional Manufacturer Narrative
E: first name and last name of initial reporter is unknown.G2: country of origin is japan.H3: product analysis of part# (b)(4), lot# 535330 during the inspection, it was observed that the image was cloudy.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: METRX SYSTEM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• Manufacturer (Section G): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 25147542
• Report Number: 1030489-2026-00010
• Device Sequence Number: 16139795
• Product Code: HRX
• UDI-Device Identifier: 00885074210353
• UDI-Public: (01)00885074210353(11)080807(10)535330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: 9560100
• Device Catalogue Number: 9560100
• Device Lot Number: 535330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown