MAUDE Adverse Event Report: SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC) SENTIO SM STIM ALLIGATR CLIP; CABLE, ELECTRODE

Catalog Number 286202017

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date during an unknown procedure there was a five (5) to ten (10) second delayed response in the system reporting mechanomyogram (mmg) events.The patient can be seen moving but the system doesn¿t send an alert for immediately.This has happened on three (3) cases during a two (2) week period.The system had been performing successfully prior to these surgeries.The system is the mmgb 81.During the cortical pedicle screw insertion, the drill is stimulated while drilling and then the ball tip is used to probe the hole.The screw is stimulated at the end.This lag has been present at all steps, not one in particular.There was no excessive energy alert.L4-5 are the usual levels they are stimulating.Surgical delay is unknown.There were no patient consequences.The procedure was successfully completed.This report is for one (1) sentio sm stim alligatr clip.This is report 3 of 5 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The complaint device was not received for investigation.The following investigation is based on the video(s) provided in the attachment(s) and the discussion with the r&d team ¿ raynham as provided in the attachment.After reviewing the video, the complaint condition could not be confirmed because based on the sentio screen in the video, it was found to have no lag/delay issues as reported in the complaint allegation.Since the device was not returned, the functional test was not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the videos) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SENTIO SM STIM ALLIGATR CLIP
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• MDR Report Key: 10045039
• MDR Text Key: 197969215
• Report Number: 1526439-2020-01018
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 286202017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1