MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.411

Device Problem Material Deformation (2976)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) as follows: it was reported that patient's periprosthetic knee fracture was treated initially on (b)(6), 2021 with a left 10 holes variable angle (va) condylar plate.Post op x-ray taken at 2 weeks revealed that the plate is bent and the femur reduction is lost.The revision surgery was performed on (b)(64), 2021 where the plate was removed and a new 14 holes va condylar plate was implanted and fracture was reduced.This report is for one (1) 4.5mm va-lcp curved condylar plate/10 hole/230mm/left.This is report 1 of 1 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.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

Product complaint # (b)(4).Investigation summary: investigation flow: damage.Visual inspection: the vacrvd condy pl/10h/230/lt (p/n: 02.124.411 & lot #: 54p0537) was returned and received at us cq.Upon visual inspection, it was observed that the plate was bent.The minor scratches were visible on the surface of plate but that doesn't impact the functionality of device.Also these scratches could have happened after implantation or during removal procedure.No other issues were identified with the returned device.Device failure/defect is identified.Complaint is confirmed and the plate received was bent.Hence confirming the allegation.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.No design discrepancy is found.Investigation conclusion: the complaint condition was confirmed for the 4.5 vacrvd condy pl/10h/230/lt (p/n: 02.124.411 & lot #: 54p0537).The potential cause of the bent issue cannot be confirmed as the plate would have experienced unintended forces after implantation.However it cannot be confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part # 02.124.411.Lot # 54p0537.Manufacturing site: mezzovico.Release to warehouse date: 20.05.2020.A manufacturing record evaluation was performed for the not sterile 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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12610351
• MDR Text Key: 281504052
• Report Number: 8030965-2021-08593
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454071
• UDI-Public: (01)07611819454071
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.411
• Device Lot Number: 54P0537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG