MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KEX152EB-CDS-
Medical Device Problem Codes	Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare facility via a medtronic representative regarding a beveled trocar to be used in an unknown spinal therapy.It was reported that the kit was opened and scrub tech noticed the bevel trocar looked ¿weird.¿ the inner stylet of the beveled trocar appeared short and damaged at the tip.T34b was used as replacement.The case went on without issue. there was no patient involved in the event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
Section e: initial reporter details are unknown 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: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
• Common Device Name: 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: 19171486
• Report Number: 1030489-2024-00330
• Device Sequence Number: 7304206
• Product Code: HRX
• UDI-Device Identifier: 00643169671645
• UDI-Public: 00643169671645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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 Expiration Date: 09/27/2024
• Device Model Number: KEX152EB-CDS-
• Device Catalogue Number: KEX152EB-CDS-
• Device Lot Number: 0228337533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/24/2024
• Date Device Manufactured: 02/21/2024
• 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