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

Model Number 5584111

Device Problems Break (1069); Noise, Audible (3273)

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

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with a pre-op diagnosis of l3/4 restenosis, l1-3 lcs.It was reported that there was revision surgery held.After plif was performed on l3/4, restenosis on l3/4 and lcs on l1-3 were performed.Initial surgery was performed on 2019/7/4 and plif was performed on l3/4.During revision surgery after right screw (cnsas/7.5*50) on l4 was removed, the replacement so56/cnmas8.5*55 was inserted, torx part of mas lock sleeve screwdriver tip broke.The mas screwdriver broke when an attempt was made to insert the 8.5mm diameter screw into the pilot hole after removing the 7.5mm diameter screw.Since the same solera screw with a different diameter was used, tapping was not performed.At the time of insertion, it seemed that a large torque was applied so that it made a strange noise.No obvious malfunction had been identified on the ratchet handle.There was no malfunction with the initial insertion implants.No fragment of the instrument remaining in the patient.There was no delay in overall procedure time.No patient symptoms or complications as a result of this event.No in-patient hospitalization or prolongation of existing hospitalization.No treatment or additional surgery performed as a result of this event.Product used correctly according to the directions given in the ifu/labeling.No further complications were reported.

Manufacturer Narrative

H6: product analysis: visual inspection confirmed approximately 3mm of instrument tip has been broken off, consistent with interface during usage.Material hardness inspection confirmed conformance to print specification.Optical examination of the fracture surface revealed a fairly flat fracture surface and circular material flow, consistent with torsional overload.This type of damage is consistent with torsional overload.Additional information: d9, g3, h3, h6.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 11026665
• MDR Text Key: 222707464
• Report Number: 1030489-2020-01812
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00643169043640
• UDI-Public: 00643169043640
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5584111
• Device Catalogue Number: 5584111
• Device Lot Number: SW18M010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR