MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMAND ADAPTION-PL 20HO T1 TI; PLATE, BONE

Catalog Number 04.503.706

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Non-union Bone Fracture (2369)

Event Date 02/23/2023

Event Type  Injury  

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.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in peru as follows: it was reported on (b)(6) 2023, that the doctor who reported the (b)(4) complaint was contacted again, indicating that he has the corresponding plate, but indicates that after reoperating the patient and placing 02 new plates in replacement of the one that broke, according to the control exam performed by the patient, both are broken.There was revision surgery :implant date (b)(6) 2023.Explant date :left: (b)(6) 2023.Right: (b)(6) 2023.The reason for removal/ revision surgery is paint, inflammation, malocclusion there was 1 hour surgical delay.Patient status/ outcome: after replacement, she is fine.To date we do not have the codes of the plates that have broken (02) and the doctor is asking for an exhaustive report.Concomitant device reported: unk screws ( part # unknown, lot # unknown, quantity unknown).This report is for one (1) matrixmand adaption-pl 20ho t1 ti this is report 1 of 2 for complaint (b)(4).

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.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment (microsoftteams-image (4), microsoftteams-image (5)).Visual analysis of the photo revealed that there was a plate and screw construct implanted laterally in the right mandibular angle.It was observed that the matrixmand adaption-pl 20ho t1 ti, p/n: 04.503.706, was fixed at two points; one at the body of the mandible and at the mandibular angle.The fracture of the plate was located near the portion fixed to the mandibular angle.The broken fragments were visible in the provided photos.No other problems identified.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for matrixmand adaption-pl 20ho t1 ti, p/n: 04.503.706.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.

Event Description

The doctor decided to only remove one plate, the second plate remained inside the patient, the doctor could not remove it, due to the "bone quality" of the patient.The doctor scheduled a new surgery to be able to remove the other pending plate.

• Brand Name: MATRIXMAND ADAPTION-PL 20HO T1 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: 16571815
• MDR Text Key: 311564449
• Report Number: 8030965-2023-03344
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819973633
• UDI-Public: (01)07611819973633
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K063790
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 48 KG