MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP CONDYLAR PLATE 4.5/5.0 R 20HO L40; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 02.124.420S

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in denmark as follows: it was reported that the product was contaminated with bodily fluids.Femur fracture, operation with a va condylar plate, (b)(6) 2022.Then on (b)(6) 2023, there was a broken plate, which was removed on (b)(6) 2023.And on (b)(6) 2023, another broken plate was removed on (b)(6) 2023.No fall or other trauma has been reported that can be related to the broken plates.There was patient involvement.This report is for one (1) va-lcp condylar plate 4.5/5.0 r 20ho l40.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hwc and hrs.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h4, h6 the product was not returned to depuy synthes, however photos were provided for review.The x-ray review found the va-lcp condylar plate 4.5/5.0 r 20ho l40 broken.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.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.The overall complaint was confirmed.As the observed condition of the [va-lcp condylar plate 4.5/5.0 r 20ho l40] would contribute to the complained device issue.  based on the investigation findings, 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.H4, h6 part number: 02.124.420s.Lot number: 739p064.Manufacturing site: mezzovico.Release to warehouse date: 03 may 2022.Expiration date: 01 apr 2032.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.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: VA-LCP CONDYLAR PLATE 4.5/5.0 R 20HO L40
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MEZZOVICO; via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18275484
• MDR Text Key: 329844079
• Report Number: 8030965-2023-15407
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K110354
• 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: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.420S
• Device Lot Number: 739P064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1