MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MICRO-ENDO(TM) SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9560547
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for microendoscopic discectomy.It was reported that it was a product that was purchased last month and when used for the first time during this operation, it was bent using a light force.The device was bent, so it could not be used; it was dealt with by using something else.When the bent part was returned, it broke.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information received that the product was not bent at the time of delivery.It was said that it broke during the very first use in surgery.It reportedly broke without applying much force.This appears to be the first occurrence, including loaner instruments.
Additional Manufacturer Narrative
G2: country of origin is japan 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: MICRO-ENDO(TM) SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24994896
• Report Number: 3003120897-2026-00780
• Device Sequence Number: 21026954
• Product Code: LXH
• UDI-Device Identifier: 00673978085975
• UDI-Public: (01)00673978085975(11)201106(10)GZ20C018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: 9560547
• Device Catalogue Number: 9560547
• Device Lot Number: GZ20C018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown