MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE DCP 2+2HO T1.25 TI; CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE

Model Number	04.503.710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4).It was reported by the sales rep in (b)(6) that during an osteotomy surgery for mandible for jaw deformity on (b)(6) 2022, it was observed that the locking mechanism was broken on both the screw and the plate devices.Another like devices were used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This report is for one (1) ti matrixmandible 2x2h dcp pl 1.25 thick device.This complaint involves two (2) devices.
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.H3, h4, h6: part number: 04.503.710; synthes lot number: 430p149; supplier lot number: n/a; release to warehouse date: 05 oct 2021; expiration date: n/a; supplier: jabil-monument.No ncrs were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the locking mechanism of the matrixmandible dcp 2+2ho t1.25 ti has broken on both the screw and the plate.No other problems was reported.A dimensional inspection was not performed for the matrixmandible dcp 2+2ho t1.25 ti due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the matrixmandible dcp 2+2ho t1.25 ti would contribute to the complained device issue.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.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: MATRIXMANDIBLE DCP 2+2HO T1.25 TI
• Common Device Name: CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14145692
• Report Number: 8030965-2022-02534
• Device Sequence Number: 4025441
• Product Code: JEY
• UDI-Device Identifier: 10887587022611
• UDI-Public: 10887587022611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 04.503.710
• Device Catalogue Number: 04.503.710S
• Device Lot Number: 430P149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2018
• 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