MAUDE Adverse Event Report: SYNTHES GMBH PLATE CUTTER FOR MIDFACE PLATES; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	03.503.039
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The plate cutter broke in the matrix midface set when the surgeon was trying to cut the plate.Procedure was completed successfully with no surgical delay.Another set was opened for a cutter.
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.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.H11 additional narrative: added: b14 (to capture dhr).H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: 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: part number: 03.503.039.Lot number: 1747702 (wo# (b)(4)).Manufacturing site: umkirch.Release to warehouse date: 23-oct-2007.A review of the device history records was performed for the finished device lot number and a nc nr-58509 was started because the feature 45,0 -1/+3mm (handle width when closed) was not manufactured in tolerance with 49,51mm.The handles were not straightened before hardening, the devices were released with a use as is.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PLATE CUTTER FOR MIDFACE PLATES
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21643550
• Report Number: 8030965-2025-02631
• Device Sequence Number: 15392558
• Product Code: HTZ
• UDI-Device Identifier: 10887587011653
• UDI-Public: (01)10887587011653(10)1747702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.503.039
• Device Lot Number: 1747702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2007
• 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 Age: 24 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG