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

Model Number 5584111

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2020

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 health care professional via manufacturer representative regarding a reducer and screwdriver used in lumbar revision posterolateral fusion with pelvic fixation.Levels implanted l3, s2ai.It was reported that for the reducer, the spring in between the handle broke apart as it was being squeezed and for the screwdriver - patient had hard cortical bone, and surgeon opts to switch straight ratcheting handle to ratcheting t-handle while screw driver and screw are still in patient.Surgeon turns handle with a lot of force and the driver breaks apart and discovered the tip of the driver had broken off and fell into the patient.The tip was identified and extracted.No other patient symptoms or complications reported.

Manufacturer Narrative

Visual and optical inspection confirmed the entire torx tip of instrument has been sheared off and the attachment pin to the internal bushing has been broken off , consistent with interface during usage.Inspection of the shaft material hardness confirmed conformance to print specification.This type of damage is consistent with torsional 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.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
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10424167
• MDR Text Key: 205683073
• Report Number: 1030489-2020-01100
• Device Sequence Number: 1
• Product Code: HXX
• 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: 11/03/2020

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: 5584111
• Device Catalogue Number: 5584111
• Device Lot Number: RS13B010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR