MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC DIAMOND/BEVEL BONE ACCESS SYSTEM; ARTHROSCOPE

Model Number	NH152PB-CDS
Medical Device Problem Codes	Leak/Splash (1354); Product Quality Problem (1506); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other - abandonment of procedure.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 from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for compression fracture.It was reported that during an intra-operative spinal procedure involving the bone cement with mixer, several issues arose when rep was not in the event.The cement was described as runny and not doughy and homogenous prior to delivery, and the cement gun was leaking saline, preventing the advancement of cement into the vertebral body.When rep came back and checked the alleged devices, it looked like the gun was advancing the cement, but there wasn't any cement in the patient or the weapon.This led to the abandonment of the case due to product failure, as there was no backup product available.The procedure was delayed, prolonging the patient's existing hospitalization.No patient complications have been reported as a result of this event.
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 the issue might be with the washers on the cement cartridges.The patient wasn't affected but case time was delayed while trying to troubleshoot as they had no other product so had to stop case.

• Brand Name: DIAMOND/BEVEL BONE ACCESS SYSTEM
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21583732
• Report Number: 1030489-2025-01322
• Device Sequence Number: 9217545
• Product Code: HRX
• UDI-Device Identifier: 00643169703599
• UDI-Public: 00643169703599
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2025
• Device Model Number: NH152PB-CDS
• Device Catalogue Number: NH152PB-CDS
• Device Lot Number: 0229866803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/08/2025
• Date Device Manufactured: 10/10/2024
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female