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

Catalog Number 02.124.410

Device Problem Break (1069)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 finland reports an event as follows: it was reported that on an unknown date that the patient´s distal femoral fracture was operated on with a va-lcp condylar plate.For the first six weeks weight bearing was not allowed.Eight weeks post-op during an in route check it was noticed that the bone was misaligned.An x-ray was taken and showed that the plate had broken.According to the patient.No new accidents had occurred.Concomitant device: unknown screws (part# unknown; lot# unknown; quantity: unknown).This report is for one 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.This is report 1 of 1 for (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: h3, h6: investigation summary: investigation selection.Investigation site: (b)(4).Selected flow(s): damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the returned item was received in mezzovico on february 22nd 2021.Item has been received not in the original packaging.Information etched on it matches to complaint system and dhr.Item is visually bent and broken post-production at level of the hole number 2.No evidence of visual non conformance manufacturing related.Dimensional inspection: the returned part was re-inspected for all the features relevant to the complaint condition.The measurable features have been found conforming to manufacturing specifications.No non conformance manufacturing related identified.Document/specification review: the affected item has been manufactured and then released to warehouse on jul 25, 2016 according relevant drawing valid from 19 feb 2016.No non conformances or document change have been identified which may be related to the complaint condition.The involved lot has been manufactured starting from the raw material art 60067383/lot 19564.In the certificate for raw material of the lot 19564 it's stated that the material is conforming to specification.Summary: as per selected investigation flow from w-m-8080 appendix a, the investigation performed didn't identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 02.124.410, lot: l064067, manufacturing site: (b)(4), release to warehouse date: july 25, 2016.A manufacturing record evaluation was performed for the finished device 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/RIGHT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11350972
• MDR Text Key: 239685388
• Report Number: 8030965-2021-01186
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.410
• Device Lot Number: L064067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 04/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention