MAUDE Adverse Event Report: DEPUY SPINE INC MMG TABLET; SUTURE,NONABSORBLE,STEEL,MONO/ MULTIFILAMENT,STERILE

Model Number 286202300

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: 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) mmg tablet.This is report 1 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.H10 additional narrative: d10: complainant part is not expected to be returned for manufacturer review/investigation.The device was voided.H3, h6: investigation summary.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the video(s) provided in the attachment(s) ¿video 3.3gp and video 3.3gp¿ and the discussion with the r&d team raynham as provided in the attachment ¿(b)(4) email from r&d team raynham¿.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.

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.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.H3, h4, h6- visual inspection was conducted of the following features: no scuffs, or cracks were found onthe housing of the control unit housing.All pins and connector jacks were properly aligned inside of their housings.The tablet screen had no cracks.Cable accessories including deltapower supply and the usb-c cable had no damage to their jackets or their over molded connectors.The control unit was built with the latest release version of firmware the overall complaint was not confirmed for the received system.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review a review of the receiving inspection (ri) for mmg tablet was conducted identifying that lot number 3000019 was released in a single batch.Batch1: lot qty were released on 17nov2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: MMG TABLET
• Type of Device: SUTURE,NONABSORBLE,STEEL,MONO/ MULTIFILAMENT,STERILE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10044739
• MDR Text Key: 191706602
• Report Number: 1526439-2020-01012
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 10705034534787
• UDI-Public: 10705034534787
• Combination Product (y/n): N
• PMA/PMN Number: K173526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2020

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: 286202300
• Device Catalogue Number: 286202300
• Device Lot Number: 3000019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 06/29/2020; 09/11/2020
• Supplement Dates FDA Received: 06/23/2020; 07/14/2020; 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1