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

Model Number	286202300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a j&j employee.A product investigation was conducted.The complaint device was evaluated and investigated by the pd engineering team.The product was returned to depuy synthes and sent to raynham pd for evaluation.The raynham pd team conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on mmg tablet.The tablet had no signs of physical damage.A functional test was performed on mmg tablet.Upon powering up the device and entering a procedure with a shorted probe and sensor, the tablet displayed a system fault and no audible alarm sounded.The tablet was not able to establish communication with a known good control unit.Admin mode was accessed.Procedure folders were copied over to kingston r&d drive then to network complaint folder for the investigation archival.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 confirmed for the mmg tablet.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A review of the receiving inspection (ri) for mmg tablet was conducted identifying that lot number 3000226 was released in one batch.Batch1: lot qty of (b)(4) units were released on 06 aug 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 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 an unknown date, the mmg tablet is broken/nonfunctioning.All the broken parts were retrieved.There were no patient consequences.Procedure outcome is unknown.This report is for one (1) mmg tablet this is report 1 of 1 for complaint (b)(4).

• Brand Name: MMG TABLET
• 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: 13943099
• Report Number: 1526439-2022-00475
• Device Sequence Number: 6505849
• Product Code: ETN
• UDI-Device Identifier: 10705034534787
• UDI-Public: (01)10705034534787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 286202300
• Device Catalogue Number: 286202300
• Device Lot Number: 3000226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• 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
• Patient Sex: Unknown