MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA 5.5/6.0; SCREWDRIVER

Model Number 5584009

Device Problem Break (1069)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op for a patient with diagnosis of scoliosis.It was reported that the instrument broke in half during final locking.It was mentioned that there were no fragments left inside the patient body.There was no additional treatment or surgery performed as a result of this event.There were no symptoms to patient or physician were reported or anticipated.Additional information received on (b)(6) 2020: it was reported that the product came in contact with the patient.There was no delay reported as a result of this event.There were no further complications reported or anticipated.

Manufacturer Narrative

H3: product analysis of product# 5584009; lot# fa17l006.Analysis summary: after visual and optical examination, it appears that the shaft of the instrument has been broken where the shaft meets the handle.There are no obvious signs of defects.This is consistent with overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: CD HORIZON SOLERA 5.5/6.0
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11093582
• MDR Text Key: 224244162
• Report Number: 1030489-2020-01874
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00643169064157
• UDI-Public: 00643169064157
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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: 5584009
• Device Catalogue Number: 5584009
• Device Lot Number: FA17L006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 12/12/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 52