MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY

Model Number	4.0NEO
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not retain the lot number which determines the date of manufacture.
Event or Problem Description
Medtronic received a report that the neck flange holes were torn.Customer indicated there was no patient injury associated with this event.
Additional Manufacturer Narrative
One sample was received.Visual inspection indicated one of the eyelets of the flange had a cut; the reported event was confirmed.It was concluded that the failure mode is not related to medtronic manufacturing process.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the neck flange holes were torn.Customer indicated there was no patient injury associated with this event.

• Brand Name: SHILEY
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6668860
• Report Number: 2936999-2017-05291
• Device Sequence Number: 1971209
• Product Code: JOH
• UDI-Device Identifier: 30884522026677
• UDI-Public: 30884522026677
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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: 06/15/2021
• Device Model Number: 4.0NEO
• Device Catalogue Number: 4.0NEO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1