MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX 90 DEG L-PL/2X2 H SHORT/REVERSIBLE/0.7MM THK; PLATE, BONE

Catalog Number	04.511.304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Part number: 04.511.304.Lot number: 854p143.Manufacturing site: mezzovico.Release to warehouse date: 08 jun 2022.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that matrix 90° l-plate short 2+2ho reversibl was broken.Review of provided photo shows that the device is broken.With the available evidence, potential cause of the event cannot be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the matrix 90° l-plate short 2+2ho reversibl would contribute to the complained device issue.Based on the investigation findings, potential cause cannot be determined and 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 complaint condition.As part of depuy synthes 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 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 china reports an event as follows: it was reported that on (b)(6) 2023 during an unknown procedure, the plate in question was broken off.Another product was used to complete the surgery.There were no adverse consequences to the patient.This report is for a ti matrix 90 deg l-pl/2x2 h short/reversible/0.7mm thk.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that there was no surgical delay and procedure was successfully completed.
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.H10 additional narrative: h3, h6: a product investigation was conducted.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 matrix 90° l-plate short 2+2ho reversibl was broken in two parts, discoloration and some deeply scratches were observed at the fracture area.Both fragments were received for evaluation.Per the matrixorthognathic surgical technique guide cut and contour the plate according to the bending template and bony anatomy using the plate cutter and the bending pliers, respectively.Bend the plate between the holes as necessary.Ensure that the plate is adapted to the bony anatomy.Note: etched lines, in 1 mm increments, to facilitate bending and placement.Precautions: confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone.Cut the implant adjacent to the screw holes.Take care to protect soft tissue from trimmed edges.Warnings: do not alter the bend of the prebent plates by more than 1 mm in either direction.Do not excessively bend the plates as it may produce internal stresses which may become the focal point for eventual breakage of the implant.A dimensional inspection for the matrix 90° l-plate short 2+2ho reversibl was not performed 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 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 matrix 90° l-plate short 2+2ho reversibl would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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: TI MATRIX 90 DEG L-PL/2X2 H SHORT/REVERSIBLE/0.7MM THK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18013553
• Report Number: 8030965-2023-13458
• Device Sequence Number: 17970570
• Product Code: JEY
• UDI-Device Identifier: 10887587023885
• UDI-Public: (01)10887587023885
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083388
• 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,Company Representative
• 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: 04.511.304
• Device Lot Number: 854P143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female