MAUDE Adverse Event Report: DEPUY SPINE INC MMG POWER SUPPLY; STIMULATOR, NERVE

Model Number	286240500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Nerve Damage (1979)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: pdq.Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date a patient underwent l4/5 microdiscectomy procedure.Postoperatively the surgeon noted the posterior spine decompressions whereby the patient has developed cauda equina syndrome with bilateral abductor weakness.No further information provided.This report is for one (1) sentio mmg power supply.This is report 4 of 5 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.H6: photo investigation: the device was not returned.A photo-investigation was performed on the images provided.Upon inspecting images under notes & attachments section, there were no issues observed with the sentio neuromonitoring which contributes to the adverse event, hence unconfirmed.The device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed as the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can't be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
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.H10 additional narrative: d9 h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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.H10 additional narrative: h3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to pd which conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on the returned devices.Units were returned to r&d with the following serial number for the control unit (cu) (286202400) sn (b)(6).(ous unit no mmgb number) and tablet (286220300) sn (b)(6).The us power cord was not returned with the unit, but an orange ous cord was.A known good us cord was used during the investigation.Visual inspection showed minor smudges were noted on the control unit.They appear to be caused by the decontamination chemical not being completely dry before closing the case.Everything else looked good.The system including the tablet and control unit (cu) was then set up and connected to power using a known good us power cord and known good mmg sensors and mmg ball tip probe.The system and the probe functionalities worked correctly.Actual measurement of the stimulation current output and sensor response were not performed.These are automatically verified at initialization during post (self-test).In this case, however, to rule out any potential concern that may be related to a faulty level of stimulation current output, the cu was sent to qualitel (sentio manufacturing facility) for additional testing.Qualitel performed end-of-line testing of the complete cu assembly, it then disassembled the cu and tested the stimulus output directly on the motherboard (mb) using the mother board tester.The cu passed all the tests performed on it.The dimensional inspection was not performed since it was not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the mmg tablet was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 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 POWER SUPPLY
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12281505
• Report Number: 1526439-2021-01614
• Device Sequence Number: 20108020
• Product Code: ETN
• UDI-Device Identifier: 10705034534923
• UDI-Public: (01)10705034534923
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 286240500
• Device Catalogue Number: 286240500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 10/19/2021; 05/02/2022
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/27/2021; 11/12/2021; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MMG BALL TIP PFR; MMG CONTROL BOX; MMG SENSORS 4 PK W GROUND; MMG TABLET; MMG BALL TIP PFR; MMG CONTROL BOX; MMG SENSORS 4 PK W GROUND; MMG TABLET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male