MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KEX152EB
Medical Device Problem Codes	Product Quality Problem (1506); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E: first name and last name of initial reporter is unknown.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.
Event or Problem Description
Information was received via healthcare provider (hcp) via manufacturer representative regarding patient having transcutaneous vertebroplasty for th11 compression fracture.It was reported that when attempting to remove the ibt stylet, there is a creaking sound and it was hard that it seemed like it could not be rotated.The pliers were taken out and attempted to remove it, but only a part could be removed and the stylet could not be removed.There were no further complications or symptoms reported as a result of this event.
Additional Manufacturer Narrative
H3: product analysis of part# kex152eb, lot# 231122648 visual and optical inspection confirmed the stylet knob of the ibt has broken.The wire was still able to be pulled out and inserted into the ibt.The damage to the ibt is consistent with overload.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.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information was received via manufacturer representative that while attempting to remove the stylet as usual under supervision, a dull sound that is not typically heard was made, and it could not be turned with the usual force.Additionally, since another ibt being used during the procedure was functioning without any issues.The reported defect occurred during first attempt of usage.

• Brand Name: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22910373
• Report Number: 9617601-2025-01201
• Device Sequence Number: 9266671
• Product Code: HRX
• UDI-Device Identifier: 00763000026912
• UDI-Public: (01)00763000026912(17)261210(10)231122648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: KEX152EB
• Device Catalogue Number: KEX152EB
• Device Lot Number: 231122648
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 10/23/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/26/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown