MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 02.124.414

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2023

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.Date of event is an unknown date in 2023.Additional procodes: hrs, hwc.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

Device report from the netherlands reports an event as follows: it was reported that (b)(6) 2023, it was discovered that a patient's plate had broken.Patient was reported to have been moving normally; there was no fall.Patient was treated on (b)(6) 2023, for a distal femur fracture.This report is for a 4.5mm va-lcp curved condylar plate/14 hole/301mm/right.This is report 1 of 1 for (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.Product code: 02.124.414s.Lot number:187p796.Manufacturing site: mezzovico.Release to warehouse date: 22 jun 2021.Expiration date: 01 jun 2031.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.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 device was found cracked.No separate fragments were observed, therefore the broken condition cannot be confirmed.The device being implanted and explanted within a 3 month gap, and a possible early weight-bearing, could have led to failure of the implant.A dimensional inspection was not performed due to post manufacturing damage.Based on the investigation findings, a potential cause cannot be established with the provided information due to be a multifactorial issue.¿the overall complaint was confirmed as the observed condition of theva-lcp condylar plate 4.5/5.0 r 14ho l30 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed: current & manufactured.Dimensional inspection: n/a 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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16853967
• MDR Text Key: 314391415
• Report Number: 8030965-2023-05550
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455924
• UDI-Public: (01)07611819455924
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414
• Device Lot Number: 187P796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention