MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE PREFORMED ORBITAL PLATE LARGE/RIGHT; PLATE, BONE

Catalog Number	04.503.812
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: investigation summary: the product was not returned to j&j medtech orthopaedics.However, photos were provided for review.The photo investigation revealed that the ti matrixmedf preform orbital pl lrg/rt was observed a missing, apparently broken fragment.The provided evidence also exhibits the plate outside of the case, however, there is no additional evidence to confirm that the implant arrived damaged.Once the product leaves j&j medtech orthopaedics control, it is unknown what environment conditions the packaged products are exposed to during that time, outside of j&j medtech orthopaedics control.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.The overall complaint was confirmed as the observed condition of the ti matrixmedf preform orbital pl lrg/rt would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history: part: 04.503.812.Lot no: l674960.Release to warehouse date: 27 dec, 2017.Manufacturing site: werk raron.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 when opening the equipment i notice that the plate is affected, missing a part.Material was not used.

• Brand Name: TI MATRIXMIDFACE PREFORMED ORBITAL PLATE LARGE/RIGHT
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON; kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22939309
• Report Number: 8030965-2025-08894
• Device Sequence Number: 13288652
• Product Code: JEY
• UDI-Device Identifier: 10887587023168
• UDI-Public: (01)10887587023168(10)L674960
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 04.503.812
• Device Lot Number: L674960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male