MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734715 SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734715

Device Problem Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that too much force was applied with the spine clamp and the t handle causing the surgeon to damage a spinous process.He stated he was unable to feel what force he was applying.There was no other procedural information provided.

Manufacturer Narrative

Additional information received from a manufacturer representative reported that the surgery was delayed by five minutes and the spinous process was fractured.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the surgeon fractured a spinous process by applying too much force with the t handle.The surgeon stated that they were unable to feel what force they were applying.There was a delay of five minutes.

Manufacturer Narrative

Additional information received from the manufacturer representative provided the gender of the patient and the lot number of the clamp.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3) the clamp was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.Both returned clamp were intact and fully functional.No problem found.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: CLAMP 9734715 SPINOUS PROCESS TALL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9210387
• MDR Text Key: 163050528
• Report Number: 1723170-2019-05282
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2020

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: 9734715
• Device Catalogue Number: 9734715
• Device Lot Number: 180409, 181019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 03/24/2020; 03/24/2020; 06/10/2020
• Supplement Dates FDA Received: 03/24/2020; 03/25/2020; 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRIVER 9735253K T-HANDLE 5MM HEX KIT.