MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734716 SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734716

Device Problem Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

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 the spinous process clamp was frozen and unable to be removed from the spinous process.The surgeon had to break the spinous process clamp to remove it.There was no reported delay and no report impact to patient outcome.

Manufacturer Narrative

H2: additional information: b5 updated.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.

Event Description

Clarification was made and neither the clamp nor spinous process was broken.The clamp was stuck and the surgeon wiggled it forward and backwards until the clamp was "broken free" to pull away from the spinous process.The suspected cause of the clamp to be stuck was likely due to a tissue being stuck in the mechanism or the screw became cross-trheaded while tightening.

Manufacturer Narrative

H2: additional information.Ime and imf codes have ben added.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 9734716 SPINOUS PROCESS SHORT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10592859
• MDR Text Key: 208920475
• Report Number: 1723170-2020-02536
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 91