MAUDE Adverse Event Report: DEPUY SPINE INC MMG SENSORS 8 PK W GROUND; NEUROSURGICAL NERVE LOCATOR

Catalog Number	286202108
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: etn.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is company employee.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on (b)(6) 2019, sentio system had a sensor fault error.There was no reported patient compromised event as part of the errors experienced.The procedure outcome was unknown.This is report 1 of 1 for complaint (b)(4).
Additional 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.
Additional 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot a review of the receiving inspection (ri) for mmg sensors 8 pk w ground was conducted identifying that lot number 00018729 was released in a single batch.Lot was released on 21-jun-2019 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.The receiving inspection 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 SENSORS 8 PK W GROUND
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9398242
• Report Number: 1526439-2019-52544
• Device Sequence Number: 2701245
• Product Code: PDQ
• UDI-Device Identifier: 10705034534756
• UDI-Public: (01)10705034534756
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 286202108
• Device Lot Number: 00018729
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 12/30/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/30/2019; 12/31/2019
• Patient Sequence Number: 1