MAUDE Adverse Event Report: SYNTHES GMBH MATMIDF L-PL 2+3HO R T0.5 TI; PLATE, BONE

Model Number 04.503.324

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/26/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in germany as follows: it was reported that interoperatively-maxillary repositioning osteosynthesis was performed in (b)(6) 2022.Metal removal was performed on (b)(6) 2022 due to instability of the maxilla, intraop the plates were found to be broken and a new osteosynthesis was necessary.The soft tissue showed a clear blue discolouration, the colouring of the removed plates is blue.Surgery delay time- max.45 min.There was patient involvement.This report is for one (1) matmidf l-pl 2+3ho r t0.5 ti.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

The procedure was completed successfully, and the patient status/outcome was good.

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.Investigation summary: 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 matmidf l-pl 2+3ho r t0.5 ti was broken in multiple pieces, all fragments were returned for evaluation.Several edges of the fractures present signs of reverse/excessive bending.The plate appears to have spots of discoloration, as it sold in sterile condition, re-use or reprocessing may compromise the structural integrity of the device, it is highly recommended to store implants in their original protective packaging, and do not remove them from the packaging until immediately before use.Prior to use, check the product expiration date and verify the integrity of the sterile packaging.The matrixmidface¿ plate and screw system surgical technique guide was reviewed.Following relevant statements were found.Precautions: if contouring is necessary, the surgeon should avoid bending the device at a screw hole.Avoid sharp bends, repetitive and reverse bending as it increases the risk of implant breakage.While no root cause can be determined for the reported issue, it is possible that the plate was over-bent during the contouring step intraoperatively, leading to weaken the overall device and leading to breakage upon implantation.A dimensional inspection for the matmidf l-pl 2+3ho r t0.5 ti was unable to be performed due to post manufacturing damage.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 matmidf l-pl 2+3ho r t0.5 ti 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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history: a device history record (dhr) review was not conducted as manufacturing records related to the provided lot number were not available.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: MATMIDF L-PL 2+3HO R T0.5 TI
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16122111
• MDR Text Key: 306913957
• Report Number: 8030965-2023-00325
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587019772
• UDI-Public: (01)10887587019772
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.324
• Device Catalogue Number: 04.503.324S
• Device Lot Number: 109L00706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATMIDF L-PL 2+3HO LE T0.5 TI.; MATMIDF L-PL 2+3HO R T0.5 TI.; MATMIDF L-PL 2+3HO R T0.5 TI.
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 75 KG