MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 4.5 MM LCP CONDYLAR PLATE; CONDYLAR PLATE FIXATION IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; september 30, 2020 is the date the literature article was published.This report is for an unknown lcp condylar plate/unknown lot.Part and lot number are unknown; udi number is unknown.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

This report is being filed after the review of the following journal article: jones b.M., nugent l., griffin s.J., (2020) femoral condylar locking compression plates: a case series.The rural district general hospital experience, journal of surgical case reports, volume 9, pages 1¿5 (united kingdom) doi: 10.1093/jscr/rjaa380.This study case series aims to examine outcomes for patients managed in a rural setting.Recent insertions of condylar locking compression plates (lcps) at a rural district general hospital were examined.Between 2014 and 2019, 50 most recent distal femoral fractures comprising of 40 women and 10 men, with mean age at presentation of 77.38 years treated with the synthes 4.5/5.0 lcp condylar plate operated at ysbyty gwynedd district general hospital (dgh) (north wales) were assessed, prior to 6 months from commencing the study to allow for adequate follow-up.Average length of follow-up was 43 weeks.The following complications were reported as follows: case 1, male, this patient is one of the four cases of failure following on from successful union.This patient was paddleboarding and was knocked onto his side by a wave.The rigid construct has acted as a lever-arm to produce a fracture above the plate tip.(fig 2).This report is for an unknown lcp condylar plate.This is report 1 of 8 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: d4: updated impacted product h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - PLATES: 4.5 MM LCP CONDYLAR PLATE
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12529746
• MDR Text Key: 275415131
• Report Number: 8030965-2021-08049
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention