MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SOLERA 4.75 PERCUTANEOUS RODS; SCREWDRIVER

Model Number 5484821

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

Information was received from a healthcare professional via a manufacturer representative regarding a patient with pre-operative dia gnosis for stenosis.Procedure or technique used was tl revision.It was reported that the screwdrivers were broken.There was no fragment left inside the patient.There was no patient symptoms or complications as a result of this event.

Manufacturer Narrative

H3.Product analysis product id : 5484821 lot no.: rs17f013 visual and optical examination identified that the tip of the driver has been sheared off and is missing and the threads are damaged.This 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.

• Brand Name: SOLERA 4.75 PERCUTANEOUS RODS
• Type of Device: SCREWDRIVER
• 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: 19199634
• MDR Text Key: 341509879
• Report Number: 1030489-2024-00353
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00613994609823
• UDI-Public: 00613994609823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 5484821
• Device Catalogue Number: 5484821
• Device Lot Number: RS17F013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male