MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TRAUMA; PLATE, FIXATION, BONE

Catalog Number UNK - CONSTRUCTS: 2.7/3.5MM VA

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2023

Event Type  Injury  

Event Description

It was reported on dec 18, 2023 that medial plate was broken as well as a few locking screw.The patient did not follow up for over a year after his 1st surgery.Revision done with bone graft.No patient consequences reported.It was unknown if there was any surgical delay.This report is for one (1) unk - constructs: 2.7/3.5mm va-lcp elbow system plate/screws.This is report 2 of 6 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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 - 510k: this report is for unk - constructs: 2.7/3.5mm va-lcp elbow system plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2023.H3, h4, h6: 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.

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: h6: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that unk - plates: trauma was observed with signs of usage and normal wear which could have been a result of implantation and explantation.In addition, deform/bent condition cannot be confirmed, as it is normal for a degree of curvature to form on the plates.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 not confirmed for unk - plates: trauma.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

This report is for an unk - plates: trauma.

• Brand Name: UNK - PLATES: TRAUMA
• Type of Device: PLATE, FIXATION, 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: 18494538
• MDR Text Key: 332679887
• Report Number: 8030965-2024-00698
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: 2.7/3.5MM VA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PRODUCT NAME UNK - CONSTRUCT: PLATE/ SCREWS; PRODUCT NAME UNK - CONSTRUCT: PLATE/ SCREWS; PRODUCT NAME UNK - CONSTRUCT: PLATE/ SCREWS; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male